BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 4821642 · Received June 5, 2015

    Report

    Report Number
    1218950-2015-03028
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Report Date
    May 18, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART XL DEFIBRILLATOR PACEMAKER WAS NOT SENSITIVE. ADDITIONAL DETAILS HAVE BEEN REQUESTED. THERE WAS NO NEGATIVE PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS CLARIFIED THAT THE EXISTING ADULT PAD USED DID NOT APPLY TO THE HEARTSTART XL+. THERE WAS NO NEGATIVE PATIENT IMPACT. ANOTHER DEVICE WAS USED TO TREAT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364556 HEARTSTART XL+ DEFIBRILLATOR/MONITOR ALS DEFIBRILLATOR MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1