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

Model Number	HOY-ADVANCE-E
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/18/2025
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 the aid was putting the patient to bed, the sling was about 4 ft high.The sid closed legs to under the bed, the leg collapsed, and the patient fell 4 ft breaking her femur.She had surgery and 3 pins placed.Complaint and ra#(b)(4) was entered into our system to have the lift returned for investigation.As of this writing, the lift has not been returned.
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.

• Brand Name: HOYER ADVANCE-E
• 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: 22920161
• Report Number: 3009402404-2025-00037
• Device Sequence Number: 15739257
• Product Code: FSA
• UDI-Device Identifier: 00810055880041
• UDI-Public: 00810055880041
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/28/2025

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: 07/30/2025
• Initial Report FDA Received Date: 08/29/2025
• 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: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 78 KG