BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2140564 · Received June 16, 2011

    Report

    Report Number
    1525712-2011-00268
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    INVACARE
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY ALLEGED. MALFUNCTION ALLEGED. THE DISTRIBUTOR ALLEGES THE CONSUMER'S DC CAR ADAPTER CORD WAS HOT TO THE TOUCH AFTER BEING PLUGGED INTO THE VEHICLE ADAPTER. MAINTENANCE HISTORY IS UNKNOWN. PRODUCT HAS NOT BEEN RETURNED FOR AN EVALUATION, 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 STATES, WHEN HE PLUGGED THE CAR ADAPTER INTO THE CIGARETTE LIGHTER, THE CORD TO THE ADAPTER ALLEGEDLY GOT HOT. THE CONSUMER UNPLUGGED THE UNIT. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE ITJ INVACARE XPO140 DC CAR ADAPT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR