BEUDAMED
    FDA Adverse Event Death Summary report: N

    FABIUS TIRO

    MDR report key: 3779675 · Received April 9, 2014

    Report

    Report Number
    9611500-2014-00032
    Event Type
    Death
    Date Received
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    BSZ
    PMA / PMN Number
    K031400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER EXPRESSED THAT THE TWO INCIDENTS MAY BE UNRELATED TO EACH OTHER AND THAT THE DEVICES NOT NECESSARILY HAVE BEEN A CONTRIBUTING FACTOR. DRAEGER MEDICAL HAS NOT RECEIVED FURTHER INFORMATION TO DATE WHICH WOULD ENABLE AN INVESTIGATION AND IS REPORTING THIS INCIDENT IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS DESATURATED FOR UNEXPLAINED REASON DURING SURGICAL PROCEDURES. ONE OF THE PATIENTS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215812 FABIUS TIRO ANESTHESIA UNIT BSZ DRAGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death