BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRX REPLACEMENT CPR METER

    MDR report key: 2112415 · Received May 24, 2011

    Report

    Report Number
    1218950-2011-01442
    Event Type
    Death
    Date Received
    May 24, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 26, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE Q-CPR METER WAS NOT RECOGNIZED BY THE DEFIBRILLATOR DURING A PT CODE. THE CUSTOMER STATED THAT PT CARE AND OUTCOME WERE NOT IMPACTED BY DEVICE BEHAVIOR. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE Q-CPR METER WAS NOT RECOGNIZED BY THE DEFIBRILLATOR DURING A PT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRX REPLACEMENT CPR METER MKJ PHILIPS HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR