BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2220538 · Received July 18, 2011

    Report

    Report Number
    1218950-2011-02050
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Report Date
    June 21, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE UNIT CONNECTED TO A PT AND IT WOULDN'T ACQUIRE AN ECG THROUGH THE THERAPY CABLE. THE CUSTOMER WENT TO RUN A OPS CHECK 2 HRS LATER AND IT WOULD NOT RECOGNIZE THE THERAPY CABLE. THE CUSTOMER REPORTED THE DEVICE FAILED OPCHECK AND THEN PASSED AFTER INSTALLING A NEW THERAPY CABLE. THERE WAS NO REPORTED ADVERSE PT INVOLVEMENT. PHILIPS BENCH EVALUATED THE DEVICE AND FOUND 3 DIFFERENT EVENTS IN DATA MANAGEMENT THAT CONFIRMS THE ORIGINAL COMPLAINT OF ECG SIGNAL NOT BEING PRESENT DURING OPERATION. PHILIPS BENCH REPLACED THE THERAPY PORT AND THERAPY CABLE TO ADDRESS THE COMPLAINT.

    Description of Event or Problem · 1

    THE UNIT WAS CONNECTED TO A PT AND IT WOULDN'T ACQUIRE AN ECG THROUGH THE THERAPY CABLE. THE CREW WENT TO RUN A OPS CHECK 2 HRS LATER AND IT WOULD NOT RECOGNIZE THE THERAPY CABLE. THE CUSTOMER REPORTED THE DEVICE FAILED OPCHECK AND THEN PASSED AFTER INSTALLING A NEW THERAPY CABLE. THERE WAS NO REPORTED ADVERSE PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE - ANDOVER M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1