BEUDAMED
    FDA Adverse Event Death Summary report: N

    MR REPLACEMENT CPR METER

    MDR report key: 2495886 · Received March 15, 2012

    Report

    Report Number
    1218950-2012-00943
    Event Type
    Death
    Date Received
    March 15, 2012
    Report Date
    February 17, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED QCPR METR DAMAGE. THE INVOLVED PATIENT DIED. THE CUSTOMER HAS REPORTED THAT THE QCPR METER DAMAGE HAD NO RELATIONSHIP TO THE PATIENT OUTCOME. CPR CAN STILL BE DELIVERED WITHOUT THE USE OF A METER. THE PHYSICAL DAMAGE TO THE QCPR METER WAS CONFIRMED. THE METER WAS TAKEN OUT OF SERVICE.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED QCPR METER DAMAGE. THE INVOLVED PATIENT DIED. THE CUSTOMER HAS REPORTED THAT THE QCPR METER DAMAGE HAD NO RELATIONSHIP TO THE PATIENT OUTCOME. CPR CAN STILL BE DELIVERED WITHOUT THE USE OF A METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MR REPLACEMENT CPR METER MKJ PHILIPS MEDICAL SYSTEMS-DUP

    Patients

    Seq Age Sex Outcome Treatment
    1