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

Model Number	HOY-ADVANCE-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/16/2025
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 call from lf reporting she fell out of her lift and needs to get a part.She says she called previously but was told that we don't provide parts.The fall happened when the caregiver was putting the sling on, then in the transfer into the chair as she got closer to her closet a piece of the sling slipped out of the spreader then she fell and hit her head on the floor.Ems and fire department were called and there was a hospital visit but that was a week later because she was dizzy and then her head started hurting.They did an mri and also determined she had a lung infection.Complaint was entered into our system.The type of sling used was not reported and end user does not have joerns sling on her original order.

• 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: 21527207
• Report Number: 3009402404-2025-00006
• Device Sequence Number: 9619114
• Product Code: FSA
• UDI-Device Identifier: 00810055880041
• UDI-Public: 00810055880041
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Was Device Available for Evaluation?: No
• 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 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: 50 YR
• Patient Sex: Female
• Patient Weight: 68 KG