BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATEX AISYS CARE STATION

    MDR report key: 5888374 · Received August 16, 2016

    Report

    Report Number
    MW5064188
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 16, 2016
    Manufacturer
    GE
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PEDIATRIC DENTAL SURGERY USING ANESTHESIA MACHINE GE/DATEX/AISYS MODEL. FOLLOWING INDUCTION OF ANESTHESIA AND PLACEMENT OF A BREATHING TUBE, THE VENTILATOR WAS TURNED ON. CO2 CAPNOGRAPHY TRACING DISAPPEARED. WHEN THE PT WAS RETURNED TO MANUAL VENTILATOR, CAPNOGRAPHY WAVES RE-APPEARED. CAPNOGRAPHY DISAPPEARED AGAIN WITH A REPEAT ATTEMPT TO PLACE THE PT ON THE VENTILATOR. DECISION WAS MADE TO CANCEL THE CASE. THE PT WAS WOKEN UP FROM THE ANESTHESIA WITHOUT SURGERY. THE ANESTHESIA MACHINE WAS APPROPRIATELY CHECKED PRIOR TO START OF ANESTHESIA. OF NOTE, THE SAME MACHINE WAS USED THE DAY PRIOR FOR PEDIATRIC DENTAL SURGERY WITHOUT COMPLICATIONS. SECONDLY, ONE OF MY NURSE ANESTHETISTS HAD A SIMILAR SITUATION WITH THE SAME TYPE OF ANESTHESIA MACHINE, AT ANOTHER HOSPITAL WE SERVICE. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: DENTAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531759 DATEX AISYS CARE STATION ANESTHESIA MACHINE BSZ GE

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other