BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINDRAY NORTH AMERICA

    MDR report key: 2232250 · Received August 25, 2011

    Report

    Report Number
    MW5021932
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 25, 2011
    Manufacturer
    MINDRAY NORTH AMERICA
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAP BAND PROCEDURE WITH THE SURGEON, THE ANESTHESIOLOGIST HAD OCCASION TO REBOOT THE ANESTHESIA MACHINE BECAUSE THE BELLOWS STUCK AND WOULD NOT VENTILATE THE PT. THE ANESTHESIOLOGIST SAID THAT USUALLY IF THE MACHINE IS REBOOTED IT FIXES ITSELF WHILE STILL VENTILATING THE PT. TODAY THAT DID NOT OCCUR. WHEN THE MACHINE WAS REBOOTED HE HAD TO HAND VENTILATE THE PT UNTIL THE MACHINE WAS ENTIRELY UP AND RUNNING WHICH TOOK ABOUT 3-4 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINDRAY NORTH AMERICA ANESTHESIA MACHINE BSZ MINDRAY NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Disability