BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTEC FLOPAC REGULATOR

    MDR report key: 782463 · Received December 27, 2004

    Report

    Report Number
    1832475-2004-00005
    Event Type
    Malfunction
    Date Received
    December 27, 2004
    Date of Event
    November 29, 2004
    Report Date
    December 22, 2004
    Manufacturer
    FLOTEC, INC.
    Product Code
    CAN
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE FLOPAC HAS BEEN DROPPED. IT ALSO APPEARS THAT THE SWIVEL BODY AND CONNECTOR BODY HAS BEEN UN-TORQUED. DAMAGE ON THE GAUGE BODY COULD HAVE BEEN DONE BY IMPROPER GAUGE ADJUSTING. THE CONCLUSION OF THE EVALUATION IS THAT THE FLOPAC UNIT WAS UN-TORQUED AND COMPONENTS WERE DAMAGED OR RENDERED IN OPERATIVE BY IMPROPER GAUGE ADJUSTING TECHNIQUE, ABUSE AND MISUSE. UNIT FAILURE WAS CAUSED BY UNK DAMAGE EVENT, NOT BY MANUFACTURING OR DESIGN DEFECT. VISUAL INSPECTION OF FLOPAC REGULATOR W/HANDLE AND CYLINDER BEFORE DISMANTLING. BY OPENING THE ON-OFF VALVE AND FLOWMETER, IT WAS EVIDENT THAT THE CYLINDER WAS EMPTY. (NO OXYGEN PRESSURE INSIDE.) HALO WELDED HANDLE ASSEMBLY HAS BEEN BENT AND IS NOT IN PROPER ALIGNMENT WITH THE FLOPAC UNIT. THE FLOPAC INGAGE IS READING 2500 PSI. THE FLATS OF THE FLOPAC CONNECTOR BODY AND THE FLATS OF THE FLOPAC SWIVEL BODY ARE NOT PROPERLY ALIGNED. THERE IS DAMAGE TO THE EDGES OF THE INGAGE ADJUSTMENT WINDOW ON THE SWIVEL BODY AND DAMAGE ALSO IN THIS SAME AREA ON THE FLOPAC CONNECTOR BODY. OBSERVATIONS DURING THE DISMANTLING OF THE FLOPAC, HANDLE FROM THE CYLINDER. THE TORQUE REQUIRED TO REMOVE THE FLOPAC UNIT FROM THE CYLINDER APPEARED TO BE BELOW THE SPECIFIED AMOUNT OF 55 FT LBS. OBSERVATIONS DURING THE DISMANTLING OF THE FLOPAC SWIVEL BODY FROM THE FLOPAC CONNECTOR BODY. (THIS OPERATION WILL OPEN UP THE INGAGE CONTAINMENT AREA FOR OBSERVATION). THE FLOPAC SWIVEL BODY AND CONNECTOR BODY WERE NOT TORQUED TO FLOTEC ENGINEERING SPECIFICATION OF 15 TO 20 FT LBS. (THESE COMPONENTS WERE UN-SCREWED BY A FLOTEC TECHNICIAN BY HAND.) THE PRESSURE GAUGES BOURDON TUBE WAS NOT ENGAGED INTO THE DECAL RING ENGAGEMENT SLOT. THE BOURDON TUBE DOES NOT HAVE THE REQUIRED AMOUNT OF THE 1/8" RADIUS BEND AS DIMENSIONED ON THE PRODUCT DRAWING. THE INGAGE BODY HAS A DAMAGED AREA ON THE SURFACE WERE THE DECAL RING RIDES ON. THERE IS A SMALL AMOUNT OF TARNISH ON THE INGAGE BODY WERE THE DECAL RING RIDES. IT APPEARS THAT THE FLOPAC UNIT HAS BEEN DROPPED. THIS WOULD EXPLAIN THE BENT HANDLE. THE FLOPAC SWIVEL BODY AND THE FLOPAC CONNECTOR HAVE BEEN UN-TORQUED. THIS WOULD EXPLAIN WHY THE FLOPAC CONNECTOR BODY AND THE FLATS OF THE FLOPAC SWIVEL BODY ARE NOT PROPERLY ALIGNED, AND IF THESE TWO PARTS WERE NOT SEPARATED PROPERLY FROM EACH OTHER, IT WOULD GIVE AN OPPORTUNITY FOR THE PRESSURE GAUGES BOURDON TUBE TO BECOME DISENGAGED WITH THE DECAL RING, AND IF THESE COMPONENTS WHERE NOT REASSEMBLED BY A TRAINED TECHNICIAN, THE PRESSURE GAUGES BOURDON TUBE DISENGAGEMENT WOULD NOT BE NOTICED. THIS WOULD EXPLAIN WHY THE DECAL RING WAS SHOWING 2500 PSI EVER WHEN THE CYLINDER CONTAINED LESS THAN THAT AMOUNT OF PRESSURE. THE DAMAGE TO THE EDGES OF THE INGAGE ADJUSTMENT WINDOW ON THE SWIVEL BODY AND DAMAGE ALSO IN THIS SAME AREA ON THE FLOPAC CONNECTOR BODY, AND THE DAMAGE TO THE PRESSURE GAUGE BODY (WERE THE DECAL RIGHT RIDES) IS EVIDENT THAT SOMEONE HAS TRIED TO ADJUST THE ZERO POSITION ON THE PRESSURE GAUGE, BUT HAS TRIED TO MOVE THE PRESSURE GAUGE BASE PERPENDICULAR TO THE FLOPAC CENTERLINE INSTEAD OF RADIALLY AROUND THE FLOPAC CENTERLINE. THE SMALL AMOUNT OF TARNISH THAT WAS FOUND ON THE PRESSURE GAUGE BODY WOULD TEND TO MAKE THE GAUGE RESPOND SLOWER TO A PRESSURE CHANGE, BUT WOULD NOT MAKE IT COMPLETELY INOPERATIVE. CONCLUSION: AFTER CAREFUL REVIEW OF THE CONDITION THAT THIS FLOPAC UNIT WAS RETURNED TO FLOTEC INC. IN, WE HAVE CONCLUDED THAT THE PRIMARY REASON THIS GAUGE WAS NOT WORKING PROPERLY WAS BECAUSE OF ABUSE AND MISUSE BY THE OWNER OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING TRANSPORTATION TO RADIOLOGY FOR A CT SCAN, A VENTILATED SICU PATIENT HAD AN HYPOXIA- INDUCED BRADYCARDIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTEC FLOPAC REGULATOR PRESSURE REGULATED INTERGRATED WITH CYLINDER VALUE CAN FLOTEC, INC. F10-XX-B03-7003P5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other