BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3060126 · Received March 20, 2013

    Report

    Report Number
    1218950-2013-00961
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 26, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A 12 LEAD FAILURE. THERE WAS NO NEGATIVE PT IMPACT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER (FSE). THE REPORTED SYMPTOM WAS REPRODUCED. THE ISSUE WAS ISOLATED TO THE ECG LEAD SET. THE ECG LEADSET WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. THE ECG LEADSET CAUSED THE 12 LEAD MALFUNCTION. REPLACEMENT OF THE CABLE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114877 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1