BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPNOMAC ULTIMA ANESTHESIA MONITOR

    MDR report key: 2767987 · Received September 27, 2012

    Report

    Report Number
    9610105-2012-00033
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    August 29, 2012
    Report Date
    August 30, 2012
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    CBQ
    PMA / PMN Number
    K923276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE STAFF OBSERVED SMOKE COMING FROM THE CAPNOMAC ALONG WITH A BURNING SMELL. THE STAFF DID NOT REPORT ANY FLAMES BEING SEEN. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPNOMAC ULTIMA ANESTHESIA MONITOR PATIENT MONITOR CBQ GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1