MAUDE Adverse Event Report: INVACARE CORPORATION INVACARE; HOYER LIFT

Model Number RPA450-1

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 01/11/2021

Event Type  Injury  

Event Description

When resident was put on an invacare hoyer lift, the straps were attached to the machine in the proper fashion, however, before tension was applied, the staff member did not notice that the strap had slipped to the top retaining hook.When tension was applied, and the resident was moved, the resident brought his arm up, grabbing the bar holding the strap, inadvertently bumped the strap, causing the slight tilt and allowing the strap to come off the end of the hook.Thus, the resident fell to the floor.Lift taken out of service: upgrade available with safety latches; ordered for installation.Transport to hospital on (b)(6) 2021.

• Brand Name: INVACARE
• Type of Device: HOYER LIFT
• Manufacturer (Section D): INVACARE CORPORATION ; one invacare way; mississauga, ontario
• MDR Report Key: 11339664
• MDR Text Key: 232404127
• Report Number: 11339664
• Device Sequence Number: 1
• Product Code: FNG
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RPA450-1
• Device Catalogue Number: 1078987
• 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: 01/19/2021
• Distributor Facility Aware Date: 01/11/2021
• Device Age: 15 YR
• Event Location: Nursing Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2021
• 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 Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 100