BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+DEFIB/MONITOR

    MDR report key: 3982838 · Received June 13, 2014

    Report

    Report Number
    1218950-2014-03378
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 23, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS TO REPORT THAT WHEN POWERING THE DEVICE ON THEY GOT A "DEFIB DEACTIVATED" MESSAGE. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351335 HEARTSTART XL+DEFIB/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1