BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1850145 · Received September 21, 2010

    Report

    Report Number
    1218950-2010-01658
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Report Date
    August 23, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEY WERE HAVING POWER ISSUES. A PHILIPS FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE AND VERIFIED THE FAILURE. THE AC POWER MODULE HAD FAILED. THE CUSTOMER REPLACED THE AC POWER MODULE WHICH RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE HAVING POWER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1