BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYONICS

    MDR report key: 446565 · Received March 5, 2003

    Report

    Report Number
    1450997-2003-03006
    Event Type
    Injury
    Date Received
    March 5, 2003
    Date of Event
    January 17, 2003
    Report Date
    March 3, 2003
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Product Code
    HIF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON UNABLE TO KEEP PREPERITONEAL DISTENTION BALLOON INFLATED DURING SURGERY - R&L INGUINAL HERNIA REPAIR. INSUFFLATOR DID NOT ALARM. BALLOONS WERE CHANGED WITHOUT SUCCESS. IT IS ESTIMATED THAT APPROXIMATELY 3X AS MUCH AIR HAD TO BE PUMPED INTO THE BALLOON TO KEEP IT INFLATED. BEFORE EXTUBATION, CRNA NOTED PUFFINESS IN THE FACE. SQ CREPITUS WAS NOTED. CO2 SATS OK. PT EXTUBATED AND OBSERVED. CREPITUS ALSO NOTED ON THE NECK AND UPPER BACK. CXR DONE WHICH SHOWED A SMALL R. PHEUMOTHORAX ALONG WITH THE CREPITUS. PT STABILIZED AND TRANSFERRED TO HOSPITAL WERE THEY WERE ADMITTED. LATER THAT DAY, ANOTHER LAPORATOMY CASE UTILLIZED A DIFFERENT INSUFFLATOR AND IT WAS NOTED THAT IT DIDN'T HOLD THE PRESSURE. A SECOND INSUFFLATOR WAS TRIED (WHICH IS THE ONE USED ON THE FIRST CASE) AND THAT ONE ALSO WAS USED WITHOUT SUCCESS. THERE WAS NO PT INJURY WITH THIS SECOND CASE. THE TWO INSUFFLATORS WERE INSPECTED AND TESTED BY THE CONTRACTED BIOMED DEPT AND WERE FOUND TO BE FUNCTIONING PROPERLY. PHYSICIAN'S OFFICE CALLED TO GET PT UPDATE. PHYSICIAN OUT OF THE TOWN TILL NEXT WEEK AND UNABLE TO GET A THOROUGH UPDATE BUT WAS TOLD THAT THE PT WAS DISCHARGED HOME IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS INSUFFLATOR (15 LPM) HIF NORTHGATE TECHNOLOGIES, INC. 6600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization