BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMMA XXL

    MDR report key: 3875095 · Received June 10, 2014

    Report

    Report Number
    1220063-2014-00021
    Event Type
    Death
    Date Received
    June 10, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 2, 2014
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 USER INFORMED, THE SVC ENGINEER TO DOWNLOAD THE VITAL DATA OF THE MONITORS DELTA (OPERATION ROOM (OR) 1, RECOVERY ROOM 3 (RR), RECOVERY ROOM 6 AND ICS IN THE RECOVERY ROOM) FOR THE TIME PERIOD (B)(4) 2014 11:22 AM UNTIL 5 PM AND TO PROVIDE IT TO THE USER. ALSO, THE LOGS OF THE ANESTHESIA DEVICE PRIMUS WERE REQUESTED, WITH WHICH THE ANESTHESIA WAS DONE. IT WAS REPORTED THAT AFTER THE OP, IT WAS TRIED TO RESUSCITATE THE PT IN THE RECOVERY ROOM. THE PT DIED. ACCORDING TO THE USER THERE WAS NO FAULT OF THE MONITORING SITE. THE USER REQUESTS THE VITAL DATA OF THE USED MONITORS AND ALSO THE DEVICE SETTINGS FROM THE LOGS OF THE PRIMUS FOR HIS DOCUMENTATION. DURING DOWNLOADING THE LOGS AND BY LOOKING AT THE TRENDS RECOVERED, THERE ARE NO ENTRIES ANYMORE. THE MONITORS WERE AT STANDBY SINCE THE EVENT OCCURRED ON (B)(6) 2014 UNTIL THE LOGS WERE SAVED ON (B)(4) 2014. THE PT WAS MONITORED BY THE MONITORS IN THE FOLLOWING ORDER: DELTA OPERATION ROOM (OR); RECOVERY ROOM (RR) 3; (B)(4). DRAEGER REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337601 GAMMA XXL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS18852 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NO