BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 4990222 · Received August 11, 2015

    Report

    Report Number
    1218950-2015-04268
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Report Date
    July 17, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER EVALUATED DEVICE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ISSUE WAS REPORTED TO PHILIPS BECAUSE AFTER THE BATTERY WAS REPLACED THE DEVICE DISPLAYED A "RED X" SHOWING ON THE PFU. THERE WAS NO SPECIFIC REPORTED MALFUNCTION FOR THE DEVICE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523999 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1