MAUDE Adverse Event Report: APEX HEALTHCARE MFG. INC HOYER LIFT; PATIENT LIFT

Model Number	HOY-ADVANCE-E
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the manufacturer, by the end user, per the end user, that per caregiver she got mrs up to use the restroom, afterwards while lifting her off of toilet, mrs starting falling so caregiver caught her and set her down juie then when to get hoyer lift to raise her up off of the floor, was raising her up with legs of lift open when moving lift, closed legs and heard a pop, started lowering mrs as a precaution when one of the tie rods snapped and lift tilted over.Mrs fell only a short distance, only injury reported at this time being some mild brusing to her knee.Complaint # (b)(4) and ra #(b)(6) were entered into our system to have the lift returned.As of this writing, the lift has not returned.
Additional Manufacturer Narrative
This report or other informtion submitted by joerns healthcare under 21 cfr part 803, and release by fda of that report.Information, does not reflect a conclusion or admission by joerns healthcare, its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.

• Brand Name: HOYER LIFT
• Common Device Name: PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG. INC; no. 6 industrial 2nd road; tou chiao industrial park; min hsuing, chai yi hsi ; TW
• Manufacturer (Section G): APEX HEALTHCARE MFG. INC; no. 6 industrial 2nd road; tou chiao industrial park; min hsuing, chai yi hsi ; TW
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 21527206
• Report Number: 3009402404-2025-00007
• Device Sequence Number: 9619113
• Product Code: FSA
• UDI-Device Identifier: 00810055880041
• UDI-Public: 00810055880041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2025

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: HOY-ADVANCE-E
• Device Catalogue Number: HOY-ADVANCE-E
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 77 KG