BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 2211947 · Received August 15, 2011

    Report

    Report Number
    2530130-2011-00037
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    November 17, 2011
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION. WILL SUBMIT A FOLLOW-UP INVESTIGATION REPORT SHOULD THE DEVICE BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE EVIDENCE SUGGESTS THAT CONTAMINATION IN THE ELECTRICAL TRAY WAS THE ROOT CAUSE OF THE FIRE IN THIS COMPLAINT.

    Description of Event or Problem · 1

    SUPERVISOR AT (B)(6) CALLED ALLEGING THE UNIT CAUGHT FIRE WHILE CHARGING.

    Description of Event or Problem · 1

    SUPERVISOR AT (B)(6) CALLED ALLEGING THE UNIT CAUGHT FIRE WHILE CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE MOBILITY PRODUCTS POWERED WHEELCHAIR ITI PRIDE MOBILITY PRODUCTS SELECT 14 XL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening