BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMO SURE HIGH FLOW INSUFFLATOR

    MDR report key: 1650721 · Received March 23, 2010

    Report

    Report Number
    2936485-2010-00281
    Event Type
    Injury
    Date Received
    March 23, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 24, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCX
    Adverse Event
    Yes
    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 INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE, THE PRESSURE WAS SET AT 15 AND NEVER ALERTED OR ALARMED WHEN THE PRESSURE WAS TO THE POINT. IT WAS FURTHER REPORTED THAT THE PRESSURE WENT UP TO 24 AND THE PATIENT IS NOW HAVING RESPIRATORY ISSUES ALLEGEDLY FROM THIS INCIDENT.

    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 Other