BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR

    MDR report key: 1991341 · Received January 26, 2011

    Report

    Report Number
    2936485-2011-00055
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 DURING A CASE, THE UNIT FAILED. IT WAS FURTHER REPORTED THAT THE UNIT HAD OPERATED INTERMITTENTLY AND LATER STOPPED WORKING. THIS CAUSED THE AIR FLOW THROUGH THE TUBING TO STOP. IT WAS FURTHER REPORTED THAT ANOTHER UNIT WAS AVAILABLE AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMO SURE XL HIGH FLOW INSUFFLATOR INSUFFLATOR HIF STRYKER ENDOSCOPY SAN JOSE 1010CE323

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK