AdverseEventReporting
Class DeviceObservation

Contains information describing any medical devices (whether suspect or concommittant) used by the subject near the time of the adverse event occurred.

Attributes
«TS» PointInTime dateExplanted dateExplanted

The date the patient stopped using the product. Medwatch 3500 form question E.7; Medwatch 3500A form question D.7; Medwatch 3500B form question C.7.

«TS» PointInTime dateImplanted dateImplanted

The date the patient began to use the product. Medwatch 3500 form question E.6; Medwatch 3500A form question D.6; Medwatch 3500B form question C.6.

DeviceInstance deviceInstance deviceInstance

Pointer to the Device Instance (and therefore more generic information about the device product) that is suspected to have caused the adverse event, product problem, or product use error.
Medwatch 3500A form question D.1 (brand name), D.2 (commond device name), D.2.b (Procom), 5, box 2.

DeviceOperator deviceOperator deviceOperator

Is this product meant to be used only one time (i.e., single-use), but was reprocessed and/or reused? Medwatch 3500 form question E.8; Medwatch 3500A form question D.8.

String otherUserText otherUserText

Was the operator or user of the device neither the patient nor a healthcare professional? If yes, the other user text should be valued. Medwatch 3500 form question E.5; Medwatch 3500A form question D.5; Medwatch 3500B form question C.5.

«TS» PointInTime therapyStartDate therapyStartDate

Medwatch 3500A form question D.11.

«TS» PointInTime therapyStopDate therapyStopDate

Medwatch 3500A form question D.11.

Boolean wasSingleUseReprocessed wasSingleUseReprocessed

Is this product meant to be used only one time (i.e., single-use), but was reprocessed and/or reused?
MedWatch 3500 form question E.8.
MedWatch 3500A form question D.8.
(note that the MedWatch 3500B and the VAERS-1 forms do not have this element).


Properties:

Alias
Classifier Behavior
Is Abstractfalse
Is Activefalse
Is Leaffalse
Keywords
NameDeviceObservation
Name Expression
NamespaceAdverseEventReporting
Owned Template Signature
OwnerAdverseEventReporting
Owning Template Parameter
PackageAdverseEventReporting
Qualified NameFHIM::AdverseEventReporting::DeviceObservation
Representation
Stereotype
Template Parameter
VisibilityPublic

Attribute Details

 dateExplanted
Public «TS» PointInTime dateExplanted

The date the patient stopped using the product. Medwatch 3500 form question E.7; Medwatch 3500A form question D.7; Medwatch 3500B form question C.7.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDeviceObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamedateExplanted
Name Expression
NamespaceDeviceObservation
Opposite
OwnerDeviceObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DeviceObservation::dateExplanted
Stereotype
Template Parameter
Type«TS» PointInTime
Upper1
Upper Value(1)
VisibilityPublic


 dateImplanted
Public «TS» PointInTime dateImplanted

The date the patient began to use the product. Medwatch 3500 form question E.6; Medwatch 3500A form question D.6; Medwatch 3500B form question C.6.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDeviceObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamedateImplanted
Name Expression
NamespaceDeviceObservation
Opposite
OwnerDeviceObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DeviceObservation::dateImplanted
Stereotype
Template Parameter
Type«TS» PointInTime
Upper1
Upper Value(1)
VisibilityPublic


 deviceInstance
Public DeviceInstance deviceInstance

Pointer to the Device Instance (and therefore more generic information about the device product) that is suspected to have caused the adverse event, product problem, or product use error.
Medwatch 3500A form question D.1 (brand name), D.2 (commond device name), D.2.b (Procom), 5, box 2.

Constraints:
Properties:

AggregationNone
Alias
AssociationsuspectedDevice_deviceInstance
Association End
ClassDeviceObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower1
Lower Value(1)
Multiplicity1
NamedeviceInstance
Name Expression
NamespaceDeviceObservation
Opposite
OwnerDeviceObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DeviceObservation::deviceInstance
Stereotype
Template Parameter
TypeDeviceInstance
Upper1
Upper Value(1)
VisibilityPublic


 deviceOperator
Public DeviceOperator deviceOperator

Is this product meant to be used only one time (i.e., single-use), but was reprocessed and/or reused? Medwatch 3500 form question E.8; Medwatch 3500A form question D.8.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDeviceObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamedeviceOperator
Name Expression
NamespaceDeviceObservation
Opposite
OwnerDeviceObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DeviceObservation::deviceOperator
Stereotype
Template Parameter
TypeDeviceOperator
Upper1
Upper Value(1)
VisibilityPublic


 otherUserText
Public String otherUserText

Was the operator or user of the device neither the patient nor a healthcare professional? If yes, the other user text should be valued. Medwatch 3500 form question E.5; Medwatch 3500A form question D.5; Medwatch 3500B form question C.5.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDeviceObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NameotherUserText
Name Expression
NamespaceDeviceObservation
Opposite
OwnerDeviceObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DeviceObservation::otherUserText
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 therapyStartDate
Public «TS» PointInTime therapyStartDate

Medwatch 3500A form question D.11.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDeviceObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NametherapyStartDate
Name Expression
NamespaceDeviceObservation
Opposite
OwnerDeviceObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DeviceObservation::therapyStartDate
Stereotype
Template Parameter
Type«TS» PointInTime
Upper1
Upper Value(1)
VisibilityPublic


 therapyStopDate
Public «TS» PointInTime therapyStopDate

Medwatch 3500A form question D.11.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDeviceObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NametherapyStopDate
Name Expression
NamespaceDeviceObservation
Opposite
OwnerDeviceObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DeviceObservation::therapyStopDate
Stereotype
Template Parameter
Type«TS» PointInTime
Upper1
Upper Value(1)
VisibilityPublic


 wasSingleUseReprocessed
Public Boolean wasSingleUseReprocessed

Is this product meant to be used only one time (i.e., single-use), but was reprocessed and/or reused?
MedWatch 3500 form question E.8.
MedWatch 3500A form question D.8.
(note that the MedWatch 3500B and the VAERS-1 forms do not have this element).

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDeviceObservation
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamewasSingleUseReprocessed
Name Expression
NamespaceDeviceObservation
Opposite
OwnerDeviceObservation
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DeviceObservation::wasSingleUseReprocessed
Stereotype
Template Parameter
TypeBoolean
Upper1
Upper Value(1)
VisibilityPublic