BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 6526879 · Received April 27, 2017

    Report

    Report Number
    1218950-2017-02777
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Report Date
    April 3, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838023680
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 CONTACTED PHILIPS HEALTHCARE TO REPORT THAT THE DEFIB PROBLEM WITH ECG READING. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT/ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT THAT THE DEFIB PROBLEM WITH ECG READING. IT WAS REPORTED THAT THE ALLEGED FAILURE WAS OBSERVED WHILE IN USE ON A PATIENT. NO ADVERSE PATIENT IMPACT WAS REPORTED TO PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309534 HEARTSTART XL+ DEFIBRILLATOR/MONITOR ALS DEFIBRILLATOR MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1