BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3060147 · Received March 20, 2013

    Report

    Report Number
    1218950-2013-00973
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 28, 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 12 LEAD ECG ISSUE. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE REPORTED SYMPTOM WAS CONFIRMED. THE ISSUE WAS ISOLATED TO THE TRUNK CABLE. THE ECG TRUNK CABLE WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE THEN PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. THE ECG TRUNK CABLE CAUSED THE MALFUNCTION. REPLACEMENT OF THE TRUNK CABLE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 12 LEAD ECG ISSUE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115113 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1