BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR

    MDR report key: 2142802 · Received June 20, 2011

    Report

    Report Number
    2936485-2011-00439
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSUFFLATOR UNIT WOULD NOT HOLD PRESSURE. IT WAS FURTHER REPORTED THAT THE PRESSURE ON THE UNIT FLUCTUATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK