BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2963039 · Received January 24, 2013

    Report

    Report Number
    1218950-2013-00266
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Report Date
    January 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED AN INABILITY TO ACQUIRE LEADS AND PADS ECG. THERE WAS NO NEGATIVE PT IMPACT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. THERE WERE NO ECG STRIPS AVAILABLE FOR REVIEW. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. SINCE THE REPORTED SYMPTOM COULD NOT BE REPRODUCED, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INABILITY TO ACQUIRE LEADS AND PADS ECG. THERE WAS NO NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34735 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1