BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADU

    MDR report key: 6429755 · Received March 23, 2017

    Report

    Report Number
    9610105-2017-00023
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    March 22, 2017
    Report Date
    March 23, 2017
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BSZ
    PMA / PMN Number
    K050676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ADVISING THAT THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS. ATTEMPTS WERE MADE AS FOLLOWS: 3/22/2017 - PHONE, 3/22/2017 - PHONE, 3/22/2017 - EMAIL. THE DATE OF MANUFACTURE WAS NOT AVAILABLE AT THE TIME OF FILING. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE INSPIRATION PROPORTIONING VALVE WAS REPLACED TO RESOLVE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, THE VENTILATOR FAILED THE SELF CHECK, BUT WAS STILL USED ON A CASE. THE UNIT STATES O2 SUPPLY FAILURE AND AIR SUPPLY FAILURE WHEN TURNING ON TO VENTILATION MODE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209898 ADU ANESTHESIA GAS MACHINE BSZ GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1