MAUDE Adverse Event Report: INVAMEX POWER STAND-UP LIFT-PLUS 9153633660; RPS350-1

Model Number NA:RPS350-1

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This incident is being reported in an abundance of caution.The alleged issue of the user falling from the lift and breaking their leg could not be confirmed, and the underlying cause could not be determined.It was unclear if the users fall was a result of a device malfunction.There was little detail on the broken leg, and it was unclear what medical treatment was sought for the injury.The pictures provided didn¿t show any obvious indication of the allegation.However, the lift does appear to be generally worn out, with damage to the hand grips, and scratches on the frame.The device serial number was unavailable.This device was potentially manufactured by invacare (b)(4), invamex, or invacare (b)(4).The medwatch will be filed under invamex.Invamex is the current manufacturer of this model of lift.Multiple attempts were made through invacare¿s customer service and consumer affairs groups to obtain further information, without success.No return of the device could be conducted due to the lack of information and lack of response from the reporter.

Event Description

A representative from arjo lifts made invacare aware of a conversation they had with a facility regarding an invacare rps350-1 patient lift.The reporter stated the user fell off the lift and broke a leg.

Manufacturer Narrative

The reporter clarified that the fall and injury were a result of improper transferring by the facilities staff, and not a result of a defect/malfunction with the device.They confirmed the staff were retrained on proper transferring techniques.

Event Description

A representative from arjo lifts made invacare aware of a conversation they had with a facility regarding an invacare rps350-1 patient lift.The reporter stated the user fell off the lift and broke a leg.

• Brand Name: POWER STAND-UP LIFT-PLUS 9153633660
• Type of Device: RPS350-1
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas
• MDR Report Key: 10088395
• MDR Text Key: 195416555
• Report Number: 9616091-2020-00020
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

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: No Information
• Device Model Number: NA:RPS350-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention