BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC VENTILATOR

    MDR report key: 6074762 · Received November 2, 2016

    Report

    Report Number
    2020676-2016-00014
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    March 1, 2016
    Report Date
    October 5, 2016
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED AND INSPECTED PER DOCUMENTS 170186 REV. 8 AND 150094 REV. 7, WHEN THE UNIT WAS HOOKED UP AND GAS WAS SUPPLIED TO THE UNIT IT WAS APPARENT THAT THERE WAS A LEAK. EVALUATION: THE UNIT WAS OPENED AND INSPECTED AND THE TUBE FORM THE SUPPLY INLET WAS DISCONNECTED. THE CASE WAS INSPECTED FOR A TUBING CLAMP (43376) THAT IS USED TO SECURE THE TUBE FROM THE SUPPLY INLET, NONE WAS FOUND. THE TUBING WAS EXAMINED AND IT APPEARS THAT THE TUBING MAY NOT HAVE BEEN FULLY SEATED AGAINST THE BOTTOM OF THE FITTING (IV311). A REVIEW OF THE LAST INSPECTION WAS DONE AND NO FINDING WERE MADE, THE INSPECTOR THAT PERFORMED THE INSPECTION COULD NOT BE INTERVIEWED [NO LONGER WITH THE COMPANY] SO TRAINING RECORDS WERE REVIEWED. THE INSPECTOR WAS TRAINED IN (B)(4) OF 2015 THE UNIT WAS INSPECTED IN (B)(4) 2016. THE HOSE WAS RECONNECTED AND TESTING WAS PERFORMED, THE UNIT WAS FOUND TO BE WITHIN FACTORY SPECIFICATIONS. THE PARTS USED IN THIS ASSEMBLY 43376 HOSE CLAMP ¼", IV 311 FITTING 1/8 TUBE 10-32 AND HB333 TUBING 1/8" I.D. ¼" O.D. POLYURETHANE WERE CHECKED FOR FITMENT. PART 43376 HOSE CLAMP ¼" HAS A MANUFACTURER'S USEABLE RANGE OF .228" TO .256". THE MAXIMUM DIAMETER OF THE IV311 WITH HB333 INSTALLED IS MEASURED AT .291". THE TUBING HB333 WHEN INSTALLED ON FITTING IV311 IS .035" BIGGER THAT THE MAXIMUM DIAMETER THAN THE CLAMP WILL ACCOMMODATE. PRODUCTION MODIFIES THIS PART TO FIT BY CUTTING OFF THE TAB UNDER THE CLAMP. ROOT CAUSE: THE TUBING WAS NOT FULLY SEATED ON THE FITTING AND THE HOSE CLAMP IS NOT SUFFICIENT TO HOLD THE TUBING ON THE FITTING, IT IS UNKNOWN IF INSPECTOR WAS ABLE TO SEE THE TUBING OR IF THE CLAMP WAS IN PLACE AT THE TIME OF INSPECTION. THIS REPORT IS SUBMITTED TO COMPLY WITH MDR MALFUNCTION NOTICE 76 FR 12473 REQUIRING THE REPORTING OF INCIDENTS INVOLVING A LIFE-SUPPORTING AND/OR LIFE-SUSTAINING DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INTERNAL OXYGEN LEAK; VENTILATOR, SERIAL NUMBER 0245. LEAK DETECTED DURING REGULAR SCHEDULED TESTING. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725030 HYPERBARIC VENTILATOR VENTILATOR CBK SECHRIST INDUSTRIES, INC. HV-500A

    Patients

    Seq Age Sex Outcome Treatment
    1