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

Model Number HOY-PRESENCE-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 02/08/2024

Event Type  Injury  

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 it was a 4 point sling (getting what kind of sling na1056p) straps were setup and everything was hooked on, staff was getting him out of bed and the care giver, helped to get the mechanics of the lift and elevate it.The hoyer was then rolled into place splitting the legs and lowering the lift, the wheelchair was facing the hoyer (front side of hoyer) and then he was being turned and was aligned with wheelchair.Before we turned him into position to put into wheelchair we noticed a popping sound appearing to be from the strap breaking loose and patient fell on his left side and fell on the left side of his back and shoulder and sustained a head injury.At that point, he was on the floor concious, alert, and oriented and was aware of what happened, was talking to (b)(6) and care giver still.Immediately, staff called 911.When they arrived within minutes and they took vital signs and shortly after transferred to the hospital.The lift has been immediately taken out of commission according to facility staff.A training video for the presence has been sent out to entire staff as well.This video came directly from our website.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: 18887666
• MDR Text Key: 337461527
• Report Number: 3009402404-2024-00007
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/09/2024

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
• Device Operator: Health Professional
• Device Model Number: HOY-PRESENCE-S
• Device Catalogue Number: HOY-PRESENCE-S
• Date Manufacturer Received: 02/09/2024
• 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 Age: 81 YR
• Patient Sex: Male