BEUDAMED
    FDA Adverse Event Death Summary report: N

    C/100

    MDR report key: 1039981 · Received May 8, 2008

    Report

    Report Number
    2510954-2008-00004
    Event Type
    Death
    Date Received
    May 8, 2008
    Date of Event
    March 28, 2008
    Report Date
    May 8, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K912910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS INDICATE THAT THIS DEVICE WAS MANUFACTURED IN 1985. THE END OF SERVICE SUPPORT FOR THE C100 WAS IN LATE 2003. THE CUSTOMER IS AWARE OF THESE ISSUES, BUT HAS ASKED THAT THE DEVICE BE CHECKED BY DRAEGER IF POSSIBLE. AN EVALUATION OF THE DEVICE BY DRAEGER IS ANTICIPATED. A FOLLOW UP REPORT WILL BE FILED IF THE EVALUATION TAKES PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT DEATH WHILE THE PATIENT WAS IN A C100 INCUBATOR. THERE WAS NO INDICATION OF ANY MALFUNCTION OF THE INCUBATOR. THE USER REPORTED THAT THE PATIENT WAS CONSIDERED A "WELL BABY" AND THEY ARE AWAITING RESULTS OF THE MEDICAL EXAMINER'S INVESTIGATION. TO DATE THEY HAVE NOT PROVIDED ANY ADDITIONAL INFORMATION ABOUT THE PATIENT. ALTHOUGH THE USER HAS INDICATED THAT THEY ARE NOT AWARE OF ANY FAILURE OF THE DEVICE, THEY HAVE REQUESTED THAT THE DEVICE GO THROUGH A ROUTINE CHECK OUT BY THE MANUFACTURER AS PART OF THEIR NORMAL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C/100 INCUBATOR, NEONATAL FMZ DRAEGER MEDICAL SYSTEMS, INC. DP05616

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death