BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2980979 · Received February 4, 2013

    Report

    Report Number
    1218950-2013-00388
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 17, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A 12 LEAD ECG FAILURE. THERE WAS NO NEGATIVE PT IMPACT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE. THE REPORTED SYMPTOM WAS REPRODUCED - THERE WAS A FAILURE TO ACQUIRE V2 AND V4. THE ECG CONNECTOR BLOCK AND THE TRUNK CABLE WERE REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. THE CAUSE OF THE REPORTED SYMPTOM CANNOT BE DETERMINED AS MULTIPLE PARTS WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A 12 LEAD ECG FAILURE. THERE WAS NO NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47461 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1