BEUDAMED
    FDA Adverse Event Death Summary report: N

    DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE E-CAIO

    MDR report key: 1790246 · Received August 4, 2010

    Report

    Report Number
    9610105-2010-00013
    Event Type
    Death
    Date Received
    August 4, 2010
    Date of Event
    July 5, 2010
    Report Date
    August 4, 2010
    Manufacturer
    GE HEALTHCARE FINLAND, OY
    Product Code
    CCL
    PMA / PMN Number
    K051092
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A UNIT WAS FAILING A LEAK TEST. THERE IS AN INDICATION IN THE COMPLAINT RECORD THAT A DEATH OR SERIOUS INJURY MAY HAVE OCCURRED, HOWEVER, NO ADDITIONAL DETAILS ARE KNOWN AT THIS TIME. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAD BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE E-CAIO CCL GE HEALTHCARE FINLAND, OY

    Patients

    Seq Age Sex Outcome Treatment
    1 Death