MAUDE Adverse Event Report: DRIVE; PATIENT LIFT

Model Number	13244
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a lift model number 13244 in which the patient was reportedly seriously injured.No details are available regarding the incident, patient, and treatment.Drive is currently investigating the incident, including attempting to retrieve the product to evaluate it.

• Brand Name: DRIVE
• Common Device Name: PATIENT LIFT
• MDR Report Key: 14977903
• Report Number: 2438477-2022-00038
• Device Sequence Number: 12184959
• Product Code: FSA
• UDI-Device Identifier: 00822383118086
• UDI-Public: 822383118086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2022
• Report Date (Section F): 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 13244
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/13/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/11/2022