MAUDE Adverse Event Report: HANDICARE USA INC. C625 MANUAL TRAVERSE; CEILING LIFT

Model Number	323117
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A senior account executive of handicare went to the facility on 7july2021 to inspect the lift.Upon inspection of the lift and carry bar, no visible defects were found.The lift was fully operational in normal condition with no issues.The sling was not present but a sph coordinator of the facility stated the sling was found to be in good condition with no defects, tears or stitching integrity issues.This investigation is ongoing.A follow-up report will be submitted when complete.
Event or Problem Description
Patient was being transferred out of avero motion bath when the shoulder attachment of the sling released from the bull horn carry bar of a c625 overhead lift.The patient fell and broke his hip.

• Brand Name: C625 MANUAL TRAVERSE
• Common Device Name: CEILING LIFT
• Manufacturer (Section D): HANDICARE USA INC.; 10888 metro ct.; maryland heights MO 63043
• MDR Report Key: 12235037
• Report Number: 3007802293-2021-00007
• Device Sequence Number: 19945331
• Product Code: FSA
• UDI-Device Identifier: 00810045510484
• UDI-Public: 00810045510484
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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: 323117
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/27/2021
• 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