MAUDE Adverse Event Report: INVACARE TAYLOR STREET RELIANT 350 STAND-UP W/POWER BASE 9153646724; LIFT, PATIENT, AC-POWERED

Model Number NA:RPS350-2

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Invacare was made aware an event which occurred in the (b)(6) involving an isa standard stand assist lift, which was manufactured by invacare (b)(4).Invacare is filing this report because the rps350 lift, made at invacare owned (b)(4), and invamex, and sold in the us has been determined to be similar in design to the isa lift.The isa lift has not been returned to invacare portugal for an evaluation at this time.If additional information becomes available, a supplemental record will be filed.

Event Description

It was reported to invacare the patient seriously cut their hand on a sharp edge located between the main frame and the hand grip on the boom of an isa stand assist lift.

Manufacturer Narrative

While the lifts are the same in some ways, it has been confirmed by invacare emea, that the same adverse event would not happen with an rps350-2 lift, due to the lift arms are a different design and in a different location then the arms on the isa standard stand assist lift.

Event Description

It was reported to invacare the patient seriously cut their hand on a sharp edge located between the main frame and the hand grip on the boom of an isa stand assist lift.

• Brand Name: RELIANT 350 STAND-UP W/POWER BASE 9153646724
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• MDR Report Key: 9412665
• MDR Text Key: 169136001
• Report Number: 1525712-2019-00031
• 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: 11/05/2019

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: NA:RPS350-2
• Device Catalogue Number: RPS350-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other