BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2180556 · Received July 27, 2011

    Report

    Report Number
    1525712-2011-00385
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    February 27, 2012
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER VISUALLY OBSERVED THE JOY STICK CHARGER WAS CHARRED AND MELTED. THE DEALER REPLACED THE JOY STICK. RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THE COMPONENT.

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1525712-2011-00385. THE COMPONENT, CHARGER MODEL #1121089, WAS RETURNED FOR AN EVALUATION. THE CHARGER'S AC POWER CORD WAS PULLED OUT OF THE CONNECTOR IT PLUGS INTO. THE AC POWER CORD'S GROUND PLUG WAS BENT. THE DC POWER CORD HAD OXIDATION NEAR ITS TERMINALS. THE CHARGER WAS RUN WITH A GOOD AC POWER CORD AND NO DISCREPANCIES WERE OBSERVED. THIS INCIDENT IS DUE TO USER ABUSE. THE DEALER VISUALLY OBSERVED THE JOY STICK CHARGER WAS CHARRED AND MELTED. THE DEALER REPLACED THE JOY STICK. (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THE COMPONENT.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE CHARGER WAS SMOLDERING AND SMOKING. THE CAREGIVER ALLEGEDLY PANICKED AND PULLED THE CORD FROM THE CHARGER, DAMAGING THE CORD. THE DEALER ALLEGES HE OBSERVED BURN DAMAGE ON THE CHARGER. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE CHARGER WAS SMOLDERING AND SMOKING. THE CAREGIVER ALLEGEDLY PANICKED AND PULLED THE CORD FROM THE CHARGER, DAMAGING THE CORD. THE DEALER ALLEGES HE OBSERVED BURN DAMAGE ON THE CHARGER. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE M41SRR

    Patients

    Seq Age Sex Outcome Treatment
    1 73 DA Other