BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3970166 · Received April 29, 2014

    Report

    Report Number
    1218950-2014-02403
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    April 10, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MJK
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY FAILS THE 3 HR HOLDING TEST. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255573 HEART START XL MJK PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1