BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO SURE HIGH FLOW INSUFFLATOR

    MDR report key: 2110364 · Received April 25, 2011

    Report

    Report Number
    2936485-2011-00252
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 OVER INSUFFLATED DURING A CASE. IT WAS FURTHER REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

    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