MAUDE Adverse Event Report: INVACARE CORPORATION WHEELCHAIR, POWERED

Model Number TDX SP

Device Problem Break (1069)

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Date 01/10/2021

Event Type  Injury  

Event Description

This invacare power chair model tdx sp serial number (b)(4) was placed into service on (b)(6) 2016 (wheelchair, powered wheelchair 890.3860).Over the last four years the tilt activating mechanism on the chair has malfunctioned six times.Each time the chair was repaired by a technician from yankee medical in burlington vt.Invacare was also notified of the malfunction each time.This latest time the tilt motor failed on (b)(6) 2020.The chair was sent to (b)(6) medical in (b)(6) for technician repair on (b)(6) 2020.The chair was returned, supposedly repaired, to the patient at home on (b)(6) 2021.The chair was apparently not repaired correctly because the tilt motor was still malfunctioning.This malfunction has the potential harm the patient because the patient has medical conditions that require the leg to be elevated.Since the chair continues to malfunction the patient is unable to properly elevate their leg as per provider orders for cellulitis and bacterial infection of the leg.It appears the chair is not designed to be sufficiently reliable to provide safe function for its intended use.Further, the distributor repair technicians do not appear trained properly to repair malfunctions of the device in a workman like manner.Fda safety report id # (b)(4).

• Brand Name: WHEELCHAIR, POWERED
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE CORPORATION
• MDR Report Key: 11177455
• MDR Text Key: 227596738
• Report Number: MW5098841
• Device Sequence Number: 1
• Product Code: ITI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/12/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDX SP
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 138