United States Health Information Knowledgebase

 

Device or Medical/Surgical Supply


Form ID: F5
Form Name: Device or Medical/Surgical Supply
Version: 1.1
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. A device includes an implant, medical equipment, or medical/surgical supply (including disposable product). 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 for this release
Data Element ID Sort Data Element Name Sort Question Number Sort Version Sort Effective Date Sort Until Date Sort
DE141 Type of device 1 1.1 03/31/2010 - -
DE144 Implantable device placement 2 1.1 03/31/2010 - -
DE147 Implantable device removal 3 1.1 03/31/2010 - -
DE150 Device name 4 1.1 03/31/2010 - -
DE153 Device manufacturer name 5 1.1 03/31/2010 - -
DE156 Device event description 6 1.1 03/31/2010 - -
DE159 Type of device defect or failure 7 1.1 03/31/2010 - -
DE162 Type of operator error 8 1.1 03/31/2010 - -
DE165 Reuse of single-use device 9 1.1 03/31/2010 - -
DE168 Device identifier(s) 10 1.1 03/31/2010 - -
DE171 Model number 11 1.1 03/31/2010 - -
DE174 Serial number 12 1.1 03/31/2010 - -
DE177 Lot or batch number 13 1.1 03/31/2010 - -
DE180 Type of other unique product identifier 14 1.1 03/31/2010 - -
DE183 Other unique product identifier 15 1.1 03/31/2010 - -
DE186 Expiration date of device 16 1.1 03/31/2010 - -
DE189 Unique device identifier 17 1.1 03/31/2010 - -
Effective Date: 03/31/2010
Until Date: - -
Update Date: - -
Submitting Organization: Agency for Healthcare Research and Quality (AHRQ)
Date of Submission: 03/31/2010
Responsible Organization: Agency for Healthcare Research and Quality (AHRQ)
Creator: John C. Moquin
Data Steward: Agency for Healthcare Research and Quality
References: No specific reference at this time
Administrative Status: Final
Administrative Status Date: 03/31/2010
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