BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONITOR FOR MEDICAL GAS

    MDR report key: 21586958 · Received March 12, 2025

    Report

    Report Number
    MW5167596
    Event Type
    Other
    Date Received
    March 12, 2025
    Date of Event
    February 22, 2025
    Report Date
    March 8, 2025
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    CCL
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    7 YEAR OLD FEMALE TO THE OPERATING ROOM FOR LAPAROSCOPIC CHOLECYSTECTOMY. AT END OF CASE AND MOVING THE PATIENT FROM THE OPERATING ROOM TABLE TO THE STRETCHER THE PATIENT DEVELOPED A BRONCHOSPASM. HER VITALS TRENDED DOWN AND SCRUB TECH/CIRCULATING RN NOTED PATIENT DID NOT HAVE A PULSE. ANESTHESIA BAGGED THE PATIENT. HER VITALS RETURNED TO BASELINE AND SHE WAS TAKEN TO PACU. ANESTHESIA NOTE - PATIENT DOING WELL IN PACU. VSS. DISCUSSED INTRAOP COURSE WITH THE PATIENT AND SON (ON THE PHONE). THE DESATURATION WAS LIKELY RELATED TO FORCEFUL BITING DOWN ON THE ETT (ENDOTRACHEAL TUBE). AFTER TALKING WITH THE SCRUB TECH DO NOT THINK PATIENT LOST PULSE. ALARM WAS FOR CHECK D-FEND - NOT GIVING ANY ETCO2 READINGS - THIS IS THE MODULE THAT CONTROLS ETCO2 (END-TIDAL CARBON DIOXIDE) - ANESTHESIA MACHINE #6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701382 MONITOR FOR MEDICAL GAS ANALYZER, GAS, OXYGEN, GASEOUS-PHASE CCL GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. E-CAIO-00

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female