BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY 14.8V, 6.3 A LI-ON BATTERY

    MDR report key: 3977221 · Received May 9, 2014

    Report

    Report Number
    1218950-2014-02659
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 17, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MJK
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS HEALTHCARE THAT THE BATTERY FOR A HEARTSTART MRX WAS UNABLE TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282231 BATTERY 14.8V, 6.3 A LI-ON BATTERY MJK PHILIPS MEDICAL SYSTEMS M3538A 12250-0048-P

    Patients

    Seq Age Sex Outcome Treatment
    1