BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDATION SYSTEMS LLC

    MDR report key: 2804116 · Received October 12, 2012

    Report

    Report Number
    MW5027326
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    SEDATIONS SYSTEMS AND SEDATION
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BASED ON A HEADACHE COMPLAINT, SOME NITROUS OXIDE FIELD SCREENING WAS DONE ON THE SEDATION SYSTEMS DISPOSABLE SEDATION-BREATHING CIRCUIT AND MASK SET. THE AREAS IDENTIFIED WERE THE ASSEMBLED PLASTIC DISTRIBUTION TUBES. THIS APPEARS TO BE A MFG DEFECT IN THE TUBE MATERIALS AND SEEMED TO WORSEN WHEN THE TUBE WAS BENT OR STRESSED. THE NITROUS LEVELS WERE ELEVATED SIGNIFICANTLY ABOVE THE STANDARD FOR THE FOLLOWING LOTS LOT #981383 AND LOT # 89364. WE SUSPENDED SERVICES, REMOVED THE PRODUCT, AND CONTACTED THE MFR. WE REQUESTED AND RECEIVED QA/QC PRESSURE TEST DATA ON LOT # 981383. THIS WAS A ONE PAGE REPORT THAT INDICATES A ¿P¿ FOR AIR PRESSURE, PULL TEST, AND VISUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEDATION SYSTEMS LLC DISPOSABLE SEDATION-BREATHING CIRCUIT AND MASK SET BSJ SEDATIONS SYSTEMS AND SEDATION 89364
    2 SEDATION SYSTEMS LLC DISPOSABLE SEDATION-BREATHING CIRCUIT AND MASK SET BSJ SEDATIONS SYSTEMS AND SEDATION 981383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other