BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2231061 · Received July 20, 2011

    Report

    Report Number
    1218950-2011-02085
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Report Date
    June 24, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEY COULD NOT ACQUIRE PADS ECG DURING A PT EVENT. THERE WAS NO REPORT OF ADVERSE PT IMPACT OR OUTCOME. PHILIPS EVALUATED THE DEVICE AND VERIFIED THE REPORTED SYMPTOM. THE THERAPY CABLE AND THERAPY PORT WERE REPLACED TO RESOLVE THE ISSUE. WE WILL CONSIDER THIS A MALFUNCTION RELATED TO AN INTERMITTENT ELECTRICAL CONNECTION BETWEEN THE THERAPY CABLE AND THE THERAPY PORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY COULD NOT ACQUIRE PADS ECG DURING A PT EVENT. THERE WAS NO REPORT OF ADVERSE PT IMPACT OR OUTCOME.

    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