MAUDE Adverse Event Report: APEX HEALTHCARE MFG. INC HML400 LIFT; PATIENT LIFT

Model Number	HML400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to the manufacturer, by the end user, per the end user, that customer called in about a lift that broke while moving a resident.There were no injuries to the resident or the staff.The resident was only 150 lbs and said that it broke at the foot part where the leg spread open when lifting the resident into the lift.Customer said that everything looked normal when putting it together in the last few days.There were no injuries to the resident or the staff.Complaint#: (b)(4) and ra #84098094 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: HML400 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: 22974727
• Report Number: 3009402404-2025-00043
• Device Sequence Number: 9370288
• Product Code: FSA
• UDI-Device Identifier: 00810055880003
• UDI-Public: 00810055880003
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: HML400
• Device Catalogue Number: HML400
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/04/2025
• 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 Sex: Unknown