BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 4203807 · Received July 23, 2014

    Report

    Report Number
    1218950-2014-04297
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 30, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THE HEARTSTART XL+ FAILED THE SELF TEST WITH A (1:34) POWER MCU CPLD MEMORY ERROR OCCURRED. THERE WAS NO REPORTED IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432421 HEARTSTART XL+ DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1