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

Model Number HOY-JOURNEY-S

Device Problem Mechanical Problem (1384)

Patient Problem Fall (1848)

Event Date 10/09/2023

Event Type  malfunction  

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 Description

It was reported to the manufacturer, by the end user, per the end user, that we purchased a hoyer journey 340 sit to stand lift about 4 months ago to help with transfers at home with my mother.While transferring her from the toilet to her wheelchair something broke in the machine that resulted in a total failure of the machine as it collapsed and lowered my mother to the floor.Complaint#: (b)(4) and ra #84093738 was entered into our system to have the lift returned for investigation.As of this writing, the lift has not been returned.

• 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: 18251042
• MDR Text Key: 330668751
• Report Number: 3009402404-2023-00045
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HOY-JOURNEY-S
• Device Catalogue Number: HOY-JOURNEY-S
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female
• Patient Weight: 68 KG