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Device or Medical/Surgical Supply, including Health Information Technology (HIT)


Form ID: F5
Form Name: Device or Medical/Surgical Supply, including Health Information Technology (HIT)
Version: 1.2
Form Short Name: Device
Synonym: Device
Definition: A device or medical/surgical supply event involves a defect, failure, or incorrect use of a device.
Setting: Hospitals, including outpatient pharmacies and outpatient departments located within the hospital
Language: U.S. English
Guide For Use: Use this form to report any patient safety event or unsafe condition involving a defect, failure, or incorrect use of a device, including an HIT device. A device includes an implant, medical equipment, or medical/surgical supply (including disposable product). An HIT device includes hardware or software that is used to electronically create, maintain, analyze, store, or receive information to aid in the diagnosis, cure, mitigation, treatment, or prevention of disease and that is not an integral part of (1) an implantable device or (2) an item of medical equipment.
For defects or events discovered prior to market approval or clinical deployment, do not use this form. If the event involves a medication or other substance, please also complete the Medication or Other Substance form. Narrative detail can be captured on the Healthcare Event Reporting Form (HERF).
Comments: None defined at this time
Description Of Change: Not Applicable
Data Element ID Sort Data Element Name Sort Question Number Sort Version Sort Effective Date Sort Until Date Sort
DE156 Device event description 1 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE141 Type of device 2 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE144 Implantable device placement 3 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE147 Implantable device removal 4 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE150 Device name 5 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE153 Device manufacturer name 6 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE168 Device identifier(s) 7 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE171 Model number 8 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE172 Software version 9 Hospital Version 1.2 04/03/2012 - -
DE173 Firmware version 10 Hospital Version 1.2 04/03/2012 - -
DE174 Serial number 11 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE177 Lot or batch number 12 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE180 Type of other unique product identifier 13 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE183 Other unique product identifier 14 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE186 Expiration date of device 15 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE189 Unique device identifier 16 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE187 Asset tag number 17 Hospital Version 1.2 04/03/2012 - -
DE190 Use of single use device 18 Hospital Version 1.2 04/03/2012 - -
DE165 Reuse of single-use device 19 Hospital Version 1.1, Hospital Version 1.2 03/31/2010 - -
DE531 Event involved medication or other substance 20 Hospital Version 1.2 04/03/2012 - -
DE534 HIT device related to event or unsafe condition 21 Hospital Version 1.2 04/03/2012 - -
DE537 Administrative/billing system component 22 Hospital Version 1.2 04/03/2012 - -
DE540 EHR component 23 Hospital Version 1.2 04/03/2012 - -
DE543 HIT device circumstances in event or unsafe condition 24 Hospital Version 1.2 04/03/2012 - -
DE546 Equipment/device function problems results 25 Hospital Version 1.2 04/03/2012 - -
DE549 Ergonomics or human/device interface issue(s) 26 Hospital Version 1.2 04/03/2012 - -
Effective Date: 04/01/2012
Until Date: - -
Update Date: 04/24/2013
Submitting Organization: Agency for Healthcare Research and Quality (AHRQ)
Date of Submission: - -
Responsible Organization: Agency for Healthcare Research and Quality (AHRQ)
Creator: Amy Helwig, MD, MS
Data Steward: Agency for Healthcare Research and Quality
References: Not Applicable
Administrative Status: Final
Administrative Status Date: 01/24/2014
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