BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR W/SIDNE (EU1)

    MDR report key: 1831924 · Received September 7, 2010

    Report

    Report Number
    2936485-2010-00690
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 20, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE ALARM ON THE UNIT WENT OFF DUE TO INTERMITTENT OVER PRESSURE AND WAS DISPLAYING A HIGH PRESSURE READING, RANGING FROM 20 MM HG TO 30 MM HG, DESPITE BEING SET AT A MUCH LOWER PRESSURE OF 15 MM HG. IT IS FURTHER REPORTED THAT THE SURGEON HAD TO RELEASE GAS VIA THE PORT TO RELIEVE PRESSURE, WHICH WAS INTERFERING WITH THE ROUTINE VENTILATION OF THE PATIENT. IT IS FURTHER REPORTED THAT IT WAS NOTED BY BIOMED THAT THE FLOW WAS SET AT <6 LITERS, WHICH MEANT THAT VENTING WAS DISABLED. IT WAS EXPLAINED THAT THE FLOW WAS AT 10 LITERS EARLIER IN THE CASE, BUT THAT THE PRESSURE WAS OUT OF CONTROL. A LOWER FLOW SETTING WAS USED IN AN INITIAL ATTEMPT TO RELIEVE THE SITUATION. IT WAS FURTHER REPORTED THAT THIS WAS OBSERVED BY BIOMED AND THAT THE PRESSURE DISPLAY DID NOT ALWAYS CORRELATE WITH THE PRESSURE EXPERIENCED BY THE SURGICAL TEAM. IT IS UNCERTAIN IF THIS WAS SIMPLY A TIME-LAG ISSUE WITH THE DISPLAY OR IF THE MANOMETER OF THE UNIT WAS FAULTY. IT IS FURTHER REPORTED THAT THE SURGERY HAD TO BE CHANGED FROM AN ENDOSCOPIC TO AN OPEN PROCEDURE. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMO SURE XL HIGH FLOW INSUFFLATOR W/SIDNE (EU1) INSUFFLATOR HIF STRYKER ENDOSCOPY SAN JOSE 1002CE095

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other