BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAEGER

    MDR report key: 820252 · Received February 14, 2007

    Report

    Report Number
    MW1041968
    Event Type
    Other
    Date Received
    February 14, 2007
    Date of Event
    September 12, 2006
    Report Date
    February 12, 2007
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A. FIRST DEVICE 10/12/06 - BACK UP BATTERIES FAILED DURING POWER OUTAGE; 11/21/06 - FIO2 READINGS ERRATIC; O2 ERRATIC READINGS; 12/7/06 - "CLOSE N2O CYLINDER" WARNING. B. SECOND DEVICE 11/3/06 - O2 ERRATIC READINGS; 11/20/06 - O2 NOT GIVING SAME READING AS GAS ANALYZER, 12/18/06 - HIGH TIDAL VOLUMES. C. THIRD DEVICE ON11/9/06 - FIO2 READINGS ERRATIC; O2 READINGS NOT CORRECT, 11/21/06 - HIGH TIDAL VOLUMES; 12/07/06 - "CLOSE N2O CYLINDER" WARNING; INDICATED LOW PIPE PRESSURE OF <43 PSI. D. FOURTH DEVICE ON 12/26/06 - DISPLAYS HIGH TIDAL VOLUMES. E. FIFTH DEVICE ON 12/28/06 - DISPLAYS HIGH TIDAL VOLUMES. F. SIXTH DEVICE ON 12/28/06 - REMOVED FROM SERVICE AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAEGER ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. APOLLO 250-08566
    2 DRAEGER ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. APOLLO 250-08567
    3 DRAEGER ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. APOLLO 250-08568
    4 DRAEGER ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. APOLLO 250-08663
    5 DRAEGER ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. APOLLO 250-08664
    6 DRAEGER ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. APOLLO 250-08665

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other