BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2041436 · Received March 9, 2011

    Report

    Report Number
    1218950-2011-00606
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED A SHOCK EQUIPMENT MALFUNCTION MESSAGE, WHERE THE FAILURE OCCURRED THE PREVIOUS NIGHT DURING AUTOTEST. THE ERROR LOG WAS CHECKED AND THERE WERE NO OTHER MESSAGES FOUND. THE CUSTOMER RAN THE OPCHECK, WHICH PASSED. THE CUSTOMER RETURNED THE DEVICE TO USE AND NO SERVICE WAS REQUESTED. SERVICE HISTORY FOR THIS DEVICE WAS REVIEWED AND THERE WERE NO OTHER CASES OF THIS SYMPTOM REPORTED TO PHILIPS. WE WERE NOT ABLE TO CONFIRM THAT A MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED A SHOCK EQUIPMENT MALFUNCTION MESSAGE, WHERE THE FAILURE OCCURRED THE PREVIOUS NIGHT DURING AUTOTEST.

    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