BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELEMETRY TRANSMITTER

    MDR report key: 1631148 · Received March 11, 2010

    Report

    Report Number
    1220063-2010-00005
    Event Type
    Death
    Date Received
    March 11, 2010
    Date of Event
    February 22, 2010
    Report Date
    February 26, 2010
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INCIDENT OCCURRED ON (B) (6) 2009, BUT DRAEGER WAS JUST NOTIFIED ABOUT THIS REPORTED INCIDENT. IT IS CLAIMED THAT THE PT WAS ADMITTED NORMALLY TO TELEMETRY. NORMAL FUNCTION, WAVEFORM AND CONTROLS WERE OBSERVED. AT SOME LATER TIME, THE PT CONDITION HAD DECLINED. IT IS CLAIMED THAT THE TELEMETERED WAVEFORM HAD DISAPPEARED AND NO ALARMS WERE ACTIVE. IT WAS REPORTED THAT THE PT WAS MOVED TO INTENSIVE CARE AND SUBSEQUENTLY PASSED AWAY. DRAEGER (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEMETRY TRANSMITTER PATIENT MONITOR MHX DRAGER MEDICAL SYSTEMS, INC. (IT/M) 749625 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NO