BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1841398 · Received September 14, 2010

    Report

    Report Number
    1218950-2010-01581
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    August 19, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE UNIT WAS REBOOTING. THE UNIT WAS EVALUATED LOCALLY, AND IT WAS FOUND THAT THE INTERNAL DATA CARD HAD MALFUNCTIONED. REPLACEMENT OF THE INTERNAL DATA CARD RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS REBOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1