MAUDE Adverse Event Report: APEX HEALTH CARE MFG DRIVE; PATIENT LIFT

Model Number	FLNP500
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879); Laceration(s) (1946)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the report received, the end user sustained "a head injury" when he fell while using a patient lift when the "cradle became disconnected from boom assembly, possibly caused by loose hardware".The end user received staples in the hospital to treat the wound.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: PATIENT LIFT
• Manufacturer (Section D): APEX HEALTH CARE MFG; no. 6, industrial 2nd road,; tou chiao industrial park,; min hsiung, shiang chiayi ; TW
• MDR Report Key: 13113087
• Report Number: 2438477-2021-00083
• Device Sequence Number: 16967960
• Product Code: FSA
• UDI-Device Identifier: 00822383990859
• UDI-Public: 822383990859
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/29/2021
• Report Date (Section F): 12/29/2021

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?: Yes
• Operator of Device: Other
• Device Model Number: FLNP500
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/29/2021
• Device Age: 19 MO
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2021
• 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: Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Date Report Sent to FDA: 12/29/2021