MAUDE Adverse Event Report: APEX HELATH CARE MFG. INC. DRIVE; LIFT

Model Number	FLNP600
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Abrasion (1689); Fall (1848); Vertebral Fracture (4520)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a patient lift.While being transferred to bed by the device the nut and bolts of the spreader bar had loosened and the patient was dropped.The lift then fell onto the resident.She hit her head.She was taken to the er and diagnosed with a fractured c6 vertebra and other minor abrasions.Afterwards she returned to hospice care where she passed away 3 weeks later with cause of death as senile degeneration.When the driver arrived to pick up the lift after the incident was reported, he did find that the cradle had come off and the bolt and nut were absent from the boom where it connects.However, upon returning the lift to the warehouse, the same bolt and nut were returned to the lift, tightened, tested and found to be in proper working condition and the lift was put back into service.The device was then isolated when the service provider became aware of the incident.

• Brand Name: DRIVE
• Common Device Name: LIFT
• Manufacturer (Section D): APEX HELATH CARE MFG. INC.; 6 industrial 2 rd; tou chiao; industrial pk,, min hsiung shiang chiayi ; TW
• MDR Report Key: 10871431
• Report Number: 2438477-2020-00056
• Device Sequence Number: 2601229
• Product Code: FSA
• UDI-Device Identifier: 00822383990873
• UDI-Public: 822383990873
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/13/2020
• Report Date (Section F): 11/13/2020

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: FLNP600
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/14/2020
• Device Age: 13 MO
• Event Location: Other
• Date Report to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2020
• 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
• Date Report Sent to FDA: 11/13/2020