BEUDAMED
    FDA Adverse Event Death Summary report: N

    SC7000

    MDR report key: 1943962 · Received December 22, 2010

    Report

    Report Number
    1220063-2010-00098
    Event Type
    Death
    Date Received
    December 22, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SC7000 DID NOT DETECT CARDIAC ARREST AND FAILED TO ALARM VISUALLY OR AUDIBLY TO ALERT THE USERS TO THE PT'S CONDITION. IT WAS ALSO REPORTED THAT THERE WAS AN ATTEMPT AT CARDIAC MASSAGE WITH NO EFFECT AND THE PT DIED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SC7000 PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NO