BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO SURE HIGH FLOW INSUFFLATOR W/ SIDNE (EU1)

    MDR report key: 3844352 · Received June 2, 2014

    Report

    Report Number
    0002936485-2014-00382
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIF
    PMA / PMN Number
    K063367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: BAD LPU/HPU; BAD PRESSURE SENSORS OR PRESSURE CONTROL VALVES; USE ERROR; OVER DUE FOR CALIBRATION. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED AT STRYKER ENDOSCOPY FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY THE PATIENT'S PH CHANGED DUE TO HIGH CO2 RESORPTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY THE PATIENT'S PH CHANGED DUE TO HIGH CO2 RESORPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321478 PNEUMO SURE HIGH FLOW INSUFFLATOR W/ SIDNE (EU1) INSUFFLATOR, LAPAROSCOPIC HIF STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1