MAUDE Adverse Event Report: INVACARE CORPORATION INVACARE RELIANT 450; SLING LIFT

Model Number RPL 450-I

Device Problem Detachment Of Device Component (1104)

Patient Problems Death (1802); Fall (1848); Injury (2348)

Event Date 10/30/2014

Event Type  Death  

Event Description

The locknut used to attach the scale and the swivel bar to the boom of the lift fell off causing the bolt to be disassembled during a transfer of a resident.The resident fell to the floor and the swivel bar and scale landed on her chest.The lift had been used less than one year.

• Brand Name: INVACARE RELIANT 450
• Type of Device: SLING LIFT
• Manufacturer (Section D): INVACARE CORPORATION; one invacare way; elyria OH 44403 621
• MDR Report Key: 4231618
• MDR Text Key: 5064125
• Report Number: MW5038953
• Device Sequence Number: 1
• Product Code: FNG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RPL 450-I
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 97 YR
• Patient Weight: 85