BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO SURE HIGH FLOW INSUFFLATOR

    MDR report key: 1735327 · Received June 15, 2010

    Report

    Report Number
    2936485-2010-00474
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Date of Event
    May 28, 2010
    Report Date
    May 28, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ALLEGEDLY, THE OCCLUSION ALARM DIDN'T GO OFF, CAUSING THE UNIT TO NOT SENSE AN OVERFLOW OF CO2. IT WAS REPORTED THAT THE PATIENT'S ABDOMEN WAS INCREASED WITH CO2, CAUSING THEIR BLOOD PRESSURE TO DECREASE RAPIDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMO SURE HIGH FLOW INSUFFLATOR INSUFFLATOR FCX STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK