BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE AISYS

    MDR report key: 1958266 · Received January 6, 2011

    Report

    Report Number
    MW5018919
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    BSZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) HOSPITAL LOCATED IN (B)(6) -PART OF THE (B)(6) MEDICAL CENTER- HAS HAD NOT ONE BUT TWO GE HEALTHCARE AISYS AND AVANCE ANESTHESIA MACHINES FAIL IN THE LAST TWO DAYS. THE FIRST MACHINE FAILED YESTERDAY - (B)(6) 2011- THE SECOND MACHINE FAILED TODAY- (B)(6) 2011-. GE SENT A FIELD ENGINEER BY THE NAME OF (B)(4). (B)(4) SPOKE EXTENSIVELY ABOUT THE ONE MACHINE, THE SECOND HAD YET TO BREAK WHEN HE WAS THERE BUT AT NO TIME DID HE MENTION A RECALL OF THIS PRODUCT. BOTH MACHINES TURNED OFF THE ANESTHETIC DELIVERY AGENT MULTIPLE TIMES AND FINALLY CEASED TO READ AND OR DELIVER THE ANESTHETIC AGENT MID-WAY THROUGH TWO SEPARATE SURGERIES. AFTER THE MACHINES WERE TURNED OFF IN BOTH INSTANCES, THE PT WAS AMBU-BAGGED AND THEN THE MACHINE RESTARTED AND THEY WERE ABLE TO DELIVER THE AGENT FOR THIRTY MINUTES BEFORE THE ANESTHETIC AGENT DELIVERY SYSTEM SHUTDOWN. BOTH TIMES, THE ATTENDING ANESTHESIOLOGIST WAS REQUIRED TO INTERVENE IN ORDER TO PREVENT PERMANENT DAMAGE TO THE PATIENTS. RISK MGMT AT (B)(6) HAS A WOMAN APPRISED OF THE SITUATION, I'M FAIRLY SURE SHE KNOWS NOTHING OF THIS RECALL. HER NAME IS (B)(6) AND HER PHONE NUMBER IS (B)(6). THE SERIAL NUMBERS ON THE MACHINES SEEM TO BE DIFFERENT THAN THE ONES IN YOUR RECALL BUT THE FAILURE SEEMS TO BE IDENTICAL IN NATURE TO THE RECALLED MACHINES. THE SERIAL NUMBERS ARE AS FOLLOWS: MACHINE #1 (B)(4). THE SECOND MACHINE HAS THE FOLLOWING NUMBERS: (B)(4). THE BIG PROBLEM WE ARE NOW FACING IS THAT AS A LEVEL 2 TRAUMA CENTER WITH 200+ BEDS, 7 OF OUR REMAINING NINE MACHINES ARE EXACTLY THE SAME AS THESE DEFECTIVE MACHINES. PLEASE MAKE CONTACT WITH THE APPROPRIATE HOSPITAL PERSONNEL TO APPRISE THEM OF YOUR RECALL WITH THE HOPES WE CAN RESOLVE THIS IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE HEALTHCARE AISYS ANESTHESIA MACHINE BSZ GE HEALTHCARE ANA200397
    2 AVANCE ANESTHESIA MACHINE ANESTHESIA MACHINE BSZ GE HEALTHCARE ANAL00679

    Patients

    Seq Age Sex Outcome Treatment
    1