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

Model Number	HOY-PRESENCEWSC-S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to the manufacturer, by the end user, per the end user, that during a lift transferring a patient from a wheelchair to a bed the strap failed.Susie states the strap was a hoyer sling, and the straps were not frayed.Fortunately, there were no injuries when asked whether the lift and sling had been removed from service and asking for pics showing that failed strap, she mentioned the sling was disposed of.When asking for an item or model # of the sling, she was not certain, but said the sling was blue.I confirmed if the main color of the sling was blue of if one of the colors on the sling was blue - she restated the main color of the sling was blue.I then told her that sling was likely not a hoyer sling as the predominant color on our slings is grey with color accents for identification.Complaint # (b)(4) was entered into our system.
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 PRESENCE 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: 21955877
• Report Number: 3009402404-2025-00016
• Device Sequence Number: 15241676
• Product Code: FSA
• UDI-Device Identifier: 00810055881499
• UDI-Public: 00810055881499
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: Lay User/Patient
• Device Model Number: HOY-PRESENCEWSC-S
• Device Catalogue Number: HOY-PRESENCEWSC-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 05/04/2025
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 126 KG