BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    MDR report key: 3905088 · Received June 10, 2014

    Report

    Report Number
    1218950-2014-03253
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 15, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PACING A PATIENT IN ROUTE TO THE HOSPITAL, THE VEHICLE HIT A BUMP IN THE ROAD AND THE UNIT SHUT OFF. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342314 BATTERY 14.8V, 6.3 AH LI-ION BATTERY MKJ PHILIPS MEDICAL SYSTEMS M3538A

    Patients

    Seq Age Sex Outcome Treatment
    1