MAUDE Adverse Event Report: JOERNS HEALTHCARE HOYER LIFT; PATIENT LIFT

Model Number	HML450
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	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to the manufacturer, by the end user, per the end user, that manufacture defect in hml450, ps provided troubleshooting/support over the phone with (caregiver), she restated the below events of the issues, but also added that the service provider that delivered the lift did not leave any contact info or user instruction manual.The caregiver was lifting the patient up out of bed with the lift when they heard an audible "pop" sound, and then the boom arm completely froze.They managed to get the patient out of the lift and back into bed, but the lift is inoperable, meaning it does not raise or lower, even with the hydraulic switch all the way open and pulling down on the boom arm.The release valve knob spins but apparentally does not function in lowering the boom.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 LIFT
• Common Device Name: PATIENT LIFT
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bay ; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• MDR Report Key: 21762873
• Report Number: 3009402404-2025-00011
• Device Sequence Number: 18290550
• Product Code: FSA
• UDI-Device Identifier: 00810055880935
• UDI-Public: 00810055880935
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HML450
• Device Catalogue Number: HML450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 04/03/2025
• 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: Male