BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 4791135 · Received May 22, 2015

    Report

    Report Number
    1218950-2015-02782
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    May 1, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE REBOOTED WHILE BEING USED TO MONITOR AND PACE A PATIENT DURING AN INTERNAL TRANSFER TO THE CATHLAB. THE PACING HAD BEEN PAUSED AND WHEN THE USER PRESSED THE PACER START BUTTON THERE WAS NO REACTION AND THEN THE DEVICE REBOOTED. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE REBOOTED WHILE BEING USED TO MONITOR AND PACE A PATIENT DURING AN INTERNAL TRANSFER TO THE CATHLAB. THE PACING HAD BEEN PAUSED AND WHEN THE USER PRESSED THE PACER START BUTTON THERE WAS NO REACTION AND THEN THE DEVICE REBOOTED. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336555 HEARTSTART XL+ DEFIBRILLATOR/MONITOR ALS DEFIBRILLATOR MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1