BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAB 'N GO III PORTABLE MEDICAL OXYGEN SYSTEM

    MDR report key: 1803592 · Received August 4, 2010

    Report

    Report Number
    1526809-2010-00002
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 7, 2010
    Manufacturer
    WESTERN/SCOTT FETZER CO.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: VISUAL EXAMINATION OF THE RETURNED UNIT FOUND THAT THE 1/2-14 NGT INLET THREADS OF THE VALVE INTEGRATED PRESSURE REGULATOR HAD BEEN SHEARED AT THE TOP OF THE STEEL CYLINDER, RESULTING IN THE REGULATOR SEPARATING FROM THE CYLINDER. THERE WERE APPROXIMATELY 2-3 THREADS LEFT ON THE REGULATOR AND THE REST OF THE THREADED PORTION OF THE INLET CONNECTION REMAINED IN THE CYLINDER NECK. TESTING WAS PERFORMED BY (B)(4) IN AN ATTEMPT TO SIMULATE THE FAILURE AND DETERMINE THE LOAD REQUIRED TO SHEAR THE CYLINDER THREADS OF THE 1/2-14 NGT INLET CONNECTION. REP SAMPLES WERE INSTALLED INTO A THREADED TEST BLOCK. A LOAD WAS THEN APPLIED, PERPENDICULAR TO THE AXIS OF THE REGULATOR AND AT APPROXIMATELY 3 1/4 INCHES ABOVE THE TOP OF THE THREADED BLOCK, UNTIL THE SAMPLES FAILED. TESTING FOUND THAT THE AVERAGE FORCE NECESSARY TO SHEAR THE THREADS WAS 1,057 POUNDS FORCE (LBF). THIS FORCE WAS FOUND TO BE CONSISTENT WITH, AND SLIGHTLY ABOVE, THE STATED ULTIMATE TENSILE STRENGTH OF THE BRASS MATERIAL. BASED UPON THE AMOUNT OF FORCE NECESSARY TO SHEAR THE INLET THREADS AND DUPLICATE THIS FAILURE, (B)(4) BELIEVES THAT THE CYLINDER AND REGULATOR SYSTEM WERE SUBJECTED TO EXTREME, EXCESSIVE FORCES THAT ARE NOT EXPECTED OR TYPICALLY EXPERIENCED DURING THE NORMAL USE OF THE SYSTEM. THERE WAS NO INFO PROVIDED DESCRIBING HOW THE CYLINDER SYSTEM BECAME "WEDGED," OR IN WHAT MANNER OR POSITION IT WAS "WEDGED UNDER THE HOSPITAL BED." IT IS NOT KNOWN HOW OR WHETHER THE COMPRESSED GAS CYLINDER WAS PROPERLY SECURED IN ITS USE ENVIRONMENT. HOWEVER, IT IS BELIEVED THAT PROPER SECURING AND HANDLING OF THE COMPRESSED GAS CYLINDER WOULD'VE PREVENTED SUCH AN OCCURRENCE. THERE WAS ALSO NO INFO PROVIDED REGARDING THE ATTEMPTED MANNER OF REMOVAL OF THE CYLINDER SYSTEM FROM ITS "WEDGED" CONDITION. WESTERN BELIEVES IT IS POSSIBLE THAT THE CYLINDER SYSTEM MAY HAVE BEEN SUBJECTED TO SUCH EXTREME, EXCESSIVE FORCES DURING ITS ATTEMPTED REMOVAL FROM ITS "WEDGED" CONDITION. THE OBSERVED DAMAGE TO THE REGULATOR SHROUD (I.E., LARGE CRACK ACROSS THE FRONT FACE) SUGGESTS THE APPLICATION OF SUCH EXCESSIVE FORCE. (B)(4) CONCLUDED THAT THE EVENT THAT LED TO THE SUBJECTION OF EXCESSIVE FORCES ON THE CYLINDER SYSTEM WAS THE RESULT OF IMPROPER HANDLING AND SECURING OF THE CYLINDER, AND THE FAILURE TO ADHERE TO PROPER SAFETY MEASURES AND PRACTICES RELATED TO THE SAFE HANDLING OF COMPRESSED GAS CYLINDERS.

    Description of Event or Problem · 1

    A GRAB 'N GO III PORTABLE MEDICAL OXYGEN SYSTEM WAS WEDGED UNDER A HOSPITAL BED, AND WHEN IT WAS PULLED OUT, THE HEAD DETACHED FROM THE CYLINDER. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAB 'N GO III PORTABLE MEDICAL OXYGEN SYSTEM GAS CYLINDER PRESSURE REGULATOR CAN WESTERN/SCOTT FETZER CO. PRX-9369 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1