BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO SURE HIGH FLOW INSUFFLATOR

    MDR report key: 2050036 · Received March 14, 2011

    Report

    Report Number
    2936485-2011-00153
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT EXPERIENCED A HIGH FLOW ERROR. IT WAS FURTHER REPORTED THAT THE UNIT WOULD NOT HOLD PRESSURE.

    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