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

Model Number	HOY-ADVANCE-E
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report or other information 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.
Event or Problem Description
It was reported to the manufacturer, by the end user, per the end user, that customer called and said piece of lift broke off.My lift is only 3 months old and the mast bolt sheared causing my wife to fall.She weighs 170 lbs.Which is way below capacity.I had to get a bolt from home depot to make it operational because i use it daily.I need a replacement because i am afraid, she may have another fall.He sent in pics showing a bent mast tightening knob and sheered metal on the mast of this lift updated information on the incident put in the fall notes above.Medical supplies now had already sent a replacement notification is now complete.End user was not consistent in his original report for the incident as noted above.Complaint # (b)(4) and ra #(b)(4) were entered into our system to have the lift returned for investigation.

• 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 bsy ; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• MDR Report Key: 22880126
• Report Number: 3009402404-2025-00035
• Device Sequence Number: 21167006
• 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): 08/22/2025

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: Other
• Device Model Number: HOY-ADVANCE-E
• Device Catalogue Number: HOY-ADVANCE-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 77 KG