BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/5 ADU CARESTATION

    MDR report key: 6180796 · Received December 16, 2016

    Report

    Report Number
    9610105-2016-00086
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 17, 2016
    Report Date
    December 16, 2016
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BSZ
    PMA / PMN Number
    K050676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING GE HEALTHCARE TECHNICIAN CHECKOUT. IT WAS NOTICED THAT THERE WERE NUMEROUS COUNTER PRESSURE FAIL MESSAGES (33) AND ASSOCIATED ERRORS IN THE FGC (FRESH GAS UNIT). THE COUNTER PRESSURE SENSOR BOARD WAS REPLACED AND CALIBRATED TO FIX THE REPORTED ISSUE. PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING PATIENT USE, THE UNIT HAD VENTILATION COMMUNICATION ERROR WITH VENTILATOR FAILURE. THE USERS SWITCHED TO MANUAL TO FINISH THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832042 S/5 ADU CARESTATION ANESTHESIA GAS MACHINE BSZ GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1