BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/5 ANESTHESIA MONITOR

    MDR report key: 2824634 · Received October 25, 2012

    Report

    Report Number
    9610105-2012-00040
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 26, 2012
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    CBQ
    PMA / PMN Number
    K002478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE S/5 ANESTHESIA MONITOR UNEXPECTEDLY TURNED OFF DURING AN OPERATION. THE PATIENT WAS LEFT UNMONITORED FOR TEN MINUTES UNTIL AN ALTERNATE MONITOR WAS OBTAINED. 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 S/5 ANESTHESIA MONITOR PATIENT MONITOR CBQ GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1