BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 3090187 · Received April 19, 2013

    Report

    Report Number
    1218950-2013-01406
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY THE FIELD SERVICE ENGINEER. THE ISSUE WAS ISOLATED TO THE TRUNK CABLE. THE TRUNK CABLE WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE THEN PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. WE ARE CONSIDERING THIS A MALFUNCTION OF THE TRUNK CABLE. REPLACEMENT OF THE TRUNK CABLE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    DURING SERVICING THE FIELD SERVICE ENGINEER NOTICED AN ISSUE WITH THE ACQUISITION OF V4. THERE WAS NO REPORT OF PT INVOLVEMENT AS THIS OCCURRED DURING SERVICING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169510 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1