BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 3922776 · Received July 9, 2014

    Report

    Report Number
    2530130-2014-00049
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    December 1, 2013
    Report Date
    June 5, 2015
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    INI
    PMA / PMN Number
    K071949
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ELECTRICAL FAULTS WITH THE DEVICE WERE FOUND. FURTHER, IT HAS BEEN DETERMINED THAT THE SCOOTER WAS AFFECTED BY THE FIRE BUT WAS NOT THE SOURCE.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER AND DATE OF MANUFACTURE HAVE NOT BEEN PROVIDED AT THIS TIME. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.

    Description of Event or Problem · 1

    RECEIVED NOTICE OF A COMPLAINT ALLEGING A FIRE OCCURRED IN A HOME WHERE A PRIDE SCOOTER WAS LOCATED.

    Description of Event or Problem · 1

    RECEIVED NOTICE OF A COMPLAINT ALLEGING A FIRE OCCURRED IN A HOME WHERE A PRIDE SCOOTER WAS LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401298 PRIDE MOBILITY PRODUCTS MOTORIZED THREE-WHEELED VEHICLE INI PRIDE MOBILITY PRODUCTS COLT PLUS SPORT N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening