BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+DEFIBRILLATOR/MONITOR

    MDR report key: 3891921 · Received February 10, 2014

    Report

    Report Number
    1218950-2014-00644
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Report Date
    January 15, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOWUP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART XL+ "SCREEN HAS INTERFERENCE, GRADUALLY GROWING, THEN SHRINKING". THERE WAS NO REPORTED PATIENT INVOLVEMENT AND/OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88764 HEARTSTART XL+DEFIBRILLATOR/MONITOR MKJ MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1