BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 3970140 · Received April 29, 2014

    Report

    Report Number
    1218950-2014-02383
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    April 7, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE THERAPY ERRORS IN THE DEVICE LOGS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255561 HEARTSTART XL+ DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1