MAUDE Adverse Event Report: APEX HEALTHCARE MFG, INC DRIVE; PATIENT LIFT, ELECTRONIC

Model Number	13242
Medical Device Problem Codes	Component Missing (2306); Material Deformation (2976)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is an electronic patient lift.We are awaiting return of the device for evaluation.We have received photos of the device.When additional information is received a follow-up submission will be tendered.The facility stated the patient lift malfunctioned during operation and the resident fell.The incident occurred while transferring the patient from a bed to a wheelchair.Lift shows signs of bent metal and bolt missing where the boom connects to mast.The lift is inoperable.The resident suffered a hip fracture.Unit was used for approximately 16 months.Unit was used by multiple patients.

• Brand Name: DRIVE
• Common Device Name: PATIENT LIFT, ELECTRONIC
• Manufacturer (Section D): APEX HEALTHCARE MFG, INC; no. 6, industrial 2nd road; tou chiao industrial park,; min hsiung, shiang chiayi ; TW
• MDR Report Key: 12204874
• Report Number: 2438477-2021-00032
• Device Sequence Number: 14734474
• Product Code: FSA
• UDI-Device Identifier: 00822383125633
• UDI-Public: 822383125633
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2021
• Report Date (Section F): 07/21/2021

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: 13242
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/18/2021
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/01/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2021
• 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: Required Intervention
• Date Report Sent to FDA: 07/21/2021