MAUDE Adverse Event Report: JOERNS HEALTHCARE INC. HOYER LIFT

Model Number HPL402

Device Problems Collapse (1099); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2021

Event Type  malfunction  

Event Description

Hoyer collapsed while pt being transferred due to faulty screw.Screw may also be design flaw as it is only component which holds device in place but does not have opening to be secured into.

• Brand Name: HOYER LIFT
• Type of Device: HOYER LIFT
• Manufacturer (Section D): JOERNS HEALTHCARE INC. ; arlington TX
• MDR Report Key: 11245121
• MDR Text Key: 229580984
• Report Number: 11245121
• Device Sequence Number: 1
• Product Code: FSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HPL402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2021
• Distributor Facility Aware Date: 01/20/2021
• Device Age: 18 MO
• Event Location: Other
• Date Report to Manufacturer: 01/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 64