BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTHEART XL

    MDR report key: 3960974 · Received May 23, 2014

    Report

    Report Number
    1218950-2014-02922
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 30, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 CONTACTED PHILIPS HEALTHCARE TO REPORT THAT THE BATTERY WAS NOT BEING CHARGED WHEN PLUGGED IN TO AC POWER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309217 HEARTHEART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1