BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1874364 · Received October 11, 2010

    Report

    Report Number
    1218950-2010-01911
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Report Date
    September 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THIS UNIT UNEXPECTEDLY POWER CYCLED. A PHILIPS FIELD SVC ENGINEER WENT TO THE CUSTOMER SITE. THE REPORTED FAILURE COULD NOT BE RECREATED. AT THE DISCRETION OF THE FSE THE BATTERY PCA WAS REPLACED. THE UNIT PASSED ALL POST-SERVICING TESTING AND REMAINS AT THE CUSTOMER SITE. BASED ON THE CUSTOMER'S REPORT, WE WILL CONSIDER THIS A FAILURE. WE CANNOT DETERMINE THE CAUSE AS THE FAILURE COULD NOT BE RECREATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THIS UNIT UNEXPECTEDLY POWER CYCLED.

    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