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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that patient reports that her caregiver was in the process of transfering patient from his shower chair and into bed when patients body got caught on the corner of the chair, causing a situation where the chair was dragged into the side of the lift with enough force to tilt it off balance causing it to fall over and strike the door.Complaint #(b)(4) and (b)(4) were entered into our system to have the lift returned for investigation.

Manufacturer Narrative

This report or other informtion submitted by joerns healthcare under 21 cfr part 803, and 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
• Type of Device: 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: 18887722
• MDR Text Key: 337462288
• Report Number: 3009402404-2024-00005
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male