BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMVEX GAS REGULATOR (OXYGEN) WITH POWER TAKE OFF

    MDR report key: 1865308 · Received September 30, 2010

    Report

    Report Number
    9617620-2010-00001
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    AMVEX CORPORATION
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY STATED THAT 18 UNITS IN THEIR FACILITY WOULD BE RETURNED TO THE MANUFACTURER. THE USER FACILITY TESTED FOUR UNITS AND FOUND LOW FLOW IN ALL FOUR. THE FACILITY SUSPECTED THAT THE CHECK VALVE (DEMAND CHECK) WAS THE CAUSE OF THE DEVICE FAILURE. THEY REMOVED THE CHECK VALVE ON TWO UNITS AND FOUND THAT FLOW STILL VARIED SIGNIFICANTLY. MANUFACTURER REPRESENTATIVES SPOKE WITH COMPLAINANT ON TWO OCCASIONS IN REFERENCE TO THE DEVICE FAILURE TO DETERMINE POSSIBLE CAUSE WHILE AWAITING PRODUCT RETURN. THE CONFIGURATION DESCRIPTION SUGGESTED THAT FLOW COULD BE RESTRICTED DUE TO OVER-TIGHTENING OF THE BUSHING USED TO CONNECT THE COUPLER TO THE GAS REGULATOR. IT WAS SUGGESTED TO THE FACILITY THAT REPLACEMENTS COULD BE PROVIDED WITH THE COUPLER ALREADY ATTACHED BY THE MANUFACTURER, ELIMINATING THE NEED FOR AN EXTRA FITTING AND POSSIBILITY OF OVER-TIGHTENING BY THE FACILITY. DESCRIBED REPLACEMENTS WERE SENT TO THE FACILITY AND UNITS WERE OPERATING AS PER REQUIREMENTS UPON INITIAL REPORTS ON (B)(6) 2010, AND FOLLOW-UP ON (B)(6) 2010. RETURNED UNITS INCLUDED TWO MANUFACTURED IN 05/2009 (INCLUDING THE UNIT INVOLVED IN REPORTED FAILURE, ELEVEN MANUFACTURED IN 09/2009, THREE MANUFACTURED IN 01/2007, AND ONE MANUFACTURED IN 08/2006). THE UNITS WERE EVALUATED ON (B)(6) 2010. EIGHTEEN UNITS WERE RETURNED AND VISUALLY INSPECTED. OF THE EIGHTEEN UNITS RETURNED, ONE COULD NOT BE MOUNTED TO A CYLINDER FOR TESTING DUE TO DAMAGE TO THE HANDLE. SEVEN UNITS PASSED TESTING FOR BOTH PRESSURE AND FLOW SPECIFICATIONS. OF THE TEN REMAINING UNITS, EIGHT PASSED PRESSURE SPECIFICATIONS BUT WERE FOUND TO HAVE LOW FLOW AND TWO FAILED FOR BOTH FLOW AND PRESSURE REQUIREMENTS. THE ROOT CAUSE OF THE LOW FLOW COULD NOT BE DETERMINED FOR ALL UNITS. FIVE OF THE UNITS WITH LOW FLOW WERE FOUND TO HAVE THE POWER TAKE OFF SCREWED TOO FAR INTO THE PORT. THIS CAN PUSH THE DEMAND CHECK STEM INWARDS, PINCHING THE ORIFICE O-RING TO THE POINT OF OBSTRUCTING THE ORIFICE AND RESTRICTING FLOW. NOT ALL UNITS WERE RETURNED INTACT. THREE UNITS WERE RETURNED WITHOUT THE DEMAND CHECK, ONE WITH MISSING WASHER AND ONE WAS MISSING THE POWER TAKE OFF. THE USER FACILITY HAD MODIFIED THESE DEVICES FOR FACILITY TESTING. FURTHER EVALUATION IS REQUIRED TO ENSURE ALL POSSIBLE ROOT CAUSES ARE CONSIDERED. THE MANUFACTURER IS REVIEWING PRODUCT LABELING AND WILL BE ADDING STATEMENTS TO INSTRUCT USERS TO ENSURE THAT WHEN ADDING FITTINGS, THE FITTINGS IMMEDIATELY ATTACHED TO THE UNIT MUST BE HELD WITH A WRENCH TO ENSURE OVER-TIGHTENING DOES NOT OCCUR AS THIS MAY CAUSE RESTRICTED FLOW. AS A PREVENTIVE MEASURE, THE MANUFACTURER IS ALSO REVIEWING THE DESIGN OF THE BODY ADAPTER (B)(4). THIS MAY REDUCE THE POSSIBILITY THAT THE DEMAND CHECK STEM COULD BE PUSHED INWARDS FROM OVER-TIGHTENING OF ADDITIONAL FITTINGS BY THE USER. ADDITIONAL INFORMATION WILL BE PROVIDED TO THE FDA IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE EQUIPMENT MANAGER FOR RESPIRATORY CARE OF A USER FACILITY REPORTED THAT A CLICK-STYLE 15 LPM OXYGEN REGULATOR WITH POWER TAKE OFF AT THE AUXILIARY PORT WAS CONNECTED TO A TRANSPORT VENTILATOR (V-60 BI-PAP VENTILATOR) WITHIN THE FACILITY. A VENTILATOR ALARM, BELIEVED BY THE COMPLAINANT TO BE THE OXYGEN INLET ALARM, WENT OFF. THE VENTILATOR WAS IMMEDIATELY HOOKED UP TO A WALL OUTLET AND TREATMENT CONTINUED. THE USER FACILITY TESTED THE DEVICE FOR PRESSURE AND FLOW AND FOUND BOTH TO BE VERY LOW. THE COMPLAINANT STATED HE LATER TESTED FOUR REGULATORS OF THE SAME CONFIGURATION AND FLOW WAS LOW ON THE UNITS TESTED. THE GAS REGULATOR WITH POWER TAKE OFF WAS CONNECTED WITH A DISS NUT AND NIPPLE TO A COUPLE WHICH WAS THEN CONNECTED TO A SIX FOOT HOSE LEADING TO THE VENTILATOR. COMPLAINANT FURTHER STATED THEY HAD SEVERAL UNITS SET UP IN THE SAME WAY IN THEIR FACILITY AND THEY WOULD BE RETURNING ALL TO THE MANUFACTURER. HE STATED THAT THEY BELIEVED THE PROBLEM TO BE THE CHECK VALVE INTERFERING WITH THE FLOW FROM THE REGULATOR. FLOW WAS MEASURED FROM THE POWER TAKE OFF OUTPUT USING A DIGITAL FLOWMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMVEX GAS REGULATOR (OXYGEN) WITH POWER TAKE OFF CAN AMVEX CORPORATION GR15-870PT

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSPORT VENTILATOR