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

Model Number HPL700-S2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 11/02/2022

Event Type  Injury  

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.

Event Description

It was reported to the manufacturer, by the end user, per the end user, that ds received a call from a litigation firm asking for service reports on a joerns healthcare hoyer lift with serial number (b)(4).Follow up was attempted for incident details.Was able to get in touch with facility manager, with touchpoints at manchester.He explained that a patient rolled off the patient lift due to sling detaching from unit.The facility removed the lift, inspected the unit.The facility removed the lift, inspected the unit, and found noting wrong with it.The patient had a break in one femur.Currently, the lift is in a storage area.Complaint #(b)(4) was entered into our system.

• 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: 16572321
• MDR Text Key: 311575666
• Report Number: 3009402404-2023-00009
• 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: Other
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: HPL700-S2
• Device Catalogue Number: HPL700-S2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2023
• 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; Hospitalization