BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2120467 · Received June 3, 2011

    Report

    Report Number
    1525712-2011-00236
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    April 19, 2011
    Report Date
    February 20, 2012
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. CONSUMER STATED THAT SHE HEARD A POPPING NOISE AND SMELLED SMOKE. CHAIR WAS APPROXIMATELY ONE YEAR OLD AT TIME OF INCIDENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Additional Manufacturer Narrative · 1

    INITIAL (B)(4) ISSUED MFG REPORT #1525712-2011-00236. INTERNAL INSPECTION REVEALED HEAT DAMAGE. THE OVERHEATING OF THE PCB AND COMPONENTS IN THE AREA OF THE OUTPUT FETS OCCURRED. THIS FAILURE IS COVERED UNDER RISK ASSESSMENT 119. DESIGN IS VIEWED AS ALARP. SOME DEGREE OF SMOKING LIKELY OCCURRED; HOWEVER, THIS WAS NOT AN INDICATION OF SUSTAINED COMBUSTION. THE ELECTRONIC MALFUNCTION OF THE CONTROLLER, INCLUDING ANY DEBRIS THAT RESULTED, WAS CONTAINED WITHIN THE METAL ENCLOSURE OF THE DEVICE. THE CABLES SHOWED NO SIGNS OF OVERHEATING. NO RISK OF SHOCK WAS PRESENT TO THE USER. NO SERIOUS INJURY ALLEGED. CONSUMER STATED THAT SHE HEARD A POPPING NOISE AND SMELLED SMOKE. CHAIR WAS APPROXIMATELY ONE YEAR OLD AT TIME OF INCIDENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE TRAM MODULE IS "FRIED." THE MODULE ALLEGEDLY MADE A POPPING NOISE AND SMELLS LIKE SMOKE. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE TRAM MODULE IS "FRIED." THE MODULE ALLEGEDLY MADE A POPPING NOISE AND SMELLS LIKE SMOKE. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE 3GTQ-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other