BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 6067700 · Received October 31, 2016

    Report

    Report Number
    2530130-2016-00137
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    July 1, 2016
    Report Date
    November 8, 2016
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    INI
    PMA / PMN Number
    K092088
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTROLLER AND TRANSAXLE ONLY WERE RETURNED AND EVALUATED. THE SMOKE AND BURNING SMELL EXPERIENCED WAS LIKELY THE RESULT OF A PCB FAILURE CONTAINED WITHIN THE METAL S-DRIVE CONTROLLER ENCLOSURE. IT IS UNKNOWN WHAT CAUSED THE PCB TO FAIL BUT THERE WAS VISUAL EVIDENCE THAT THE RETURNED COMPONENTS WERE STORED IN A MOIST AREA OR EXPOSED TO LIQUID.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION AT THIS TIME. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL THEN BE ISSUED.

    Description of Event or Problem · 1

    UNIT WAS IN STORAGE AS IT WAS BACK FOR REPAIR WHEN IT IS ALLEGED IT WAS FOUND SMOKING AND HAD A BURNING SMELL. THE CONTROLLER WAS OPENED AND APPEARED THAT THE INSIDE WAS BURNED COMPLETELY INCLUDING THE SAFETY RELAY.

    Description of Event or Problem · 1

    UNIT WAS IN STORAGE AS IT WAS BACK FOR REPAIR WHEN IT IS ALLEGED IT WAS FOUND SMOKING AND HAD A BURNING SMELL. THE CONTROLLER WAS OPENED AND APPEARED THAT THE INSIDE WAS BURNED COMPLETELY INCLUDING THE SAFETY RELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718223 PRIDE MOBILITY PRODUCTS MOTORIZED THREE WHEELED VEHICLE INI PRIDE MOBILITY PRODUCTS LUNA VICTORY ECONOMY S613E N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening