BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3983067 · Received June 16, 2014

    Report

    Report Number
    1218950-2014-03424
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT DURING IMPLEMENTATION OF PHILIPS FIELD CHANGE ORDER THE DEVICE FAILED TO LOAD THE SOFTWARE. THE DEVICE WOULD RE-BOOT DURING THE SOFTWARE LOADING PROCEDURE. THE DEVICE WAS THEN UNABLE TO LOAD SOFTWARE AND TO UNABLE FULLY POWER ON FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353559 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1