BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFBRILLATOR

    MDR report key: 2140630 · Received June 16, 2011

    Report

    Report Number
    1218950-2011-01702
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT WAS REBOOTING. THERE WAS NO REPORT OF PT INVOLVEMENT. PHILIPS VERIFIED THE FAILURE. REPLACEMENT OF THE INTERNAL DATA CARD RESOLVED THE FAILURE. THE UNIT PASSED ALL POST-SERVICING TESTING AND REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS REBOOTING. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1