BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL + DEFIBRILLATOR/MONITOR

    MDR report key: 2914193 · Received December 7, 2012

    Report

    Report Number
    1218950-2012-04041
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 14, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING A RED X/NOT READY FOR USE INDICATOR AND A MESSAGE THAT SAID, "CLINICAL MODE NOT AVAILABLE DUE TO DISABLED EQUIPMENT. RUN OPCHECK" DURING PT TRANSFER TO A DIFFERENT HOSPITAL UNIT. NO ADVERSE PT IMPACT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1