MAUDE Adverse Event Report: INVACARE CORPORATION WORLDWIDE HEADQUATERS INVACARE; RELIANT 450 HOYER LIFTER

Model Number RELIANT 450

Device Problem Unintended Movement (3026)

Patient Problems Death (1802); Injury (2348)

Event Date 11/10/2020

Event Type  Death  

Event Description

On (b)(6) 2020, hoyer lift with the serial number (b)(4), made by invacare was being used to transfer a resident when the hoyer continued to move in an upward position on it's own without pressing on the remote.Pt did sustain an injury, and passed away on (b)(6) 2020.

• Brand Name: INVACARE
• Type of Device: RELIANT 450 HOYER LIFTER
• Manufacturer (Section D): INVACARE CORPORATION WORLDWIDE HEADQUATERS; 1 invacare way; elyria OH 44035 4190
• MDR Report Key: 10968458
• MDR Text Key: 220228966
• Report Number: 10968458
• Device Sequence Number: 1
• Product Code: FNG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RELIANT 450
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2020
• Distributor Facility Aware Date: 11/10/2020
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 77 YR
• Patient Weight: 64