BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1003830 · Received July 12, 2007

    Report

    Report Number
    1832475-2007-00001
    Event Type
    Other
    Date Received
    July 12, 2007
    Date of Event
    June 4, 2007
    Report Date
    June 19, 2007
    Manufacturer
    FLOTEC, INC.
    Product Code
    CAN
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD - AT THIS POINT THE UNIT HAS NOT BEEN RETURNED TO FLOTEC FOR TESTING, AND ACCORDING TO FDA, IT WILL NOT BE RETURNED FOR EVAL BECAUSE THE PERSON THAT FILED THE REPORT WANTED TO BE CONFIDENTIAL. RESULTS - BECAUSE THE UNIT WAS NOT AND WILL NOT BE RETURNED FOR EVAL, NO EVAL RESULTS COULD BE CONCLUDED. CONCLUSIONS - AT THIS POINT THE UNIT HAS NOT BEEN RETURNED TO FLOTEC FOR TESTING, AND ACCORDING TO FDA, IT WILL NOT BE RETURNED FOR EVAL BECAUSE THE PERSON THAT FILED THE REPORT WANTED TO BE CONFIDENTIAL. WITHOUT THE UNIT BEING AVAILABLE FOR REVIEW AND TESTING, FLOTEC CANNOT ESTABLISH ANY CONCLUSION AS TO WHAT MAY HAVE HAPPENED TO CAUSE THE EVENT. SO AS TO COMPLY WITH THE DIRECTIONS GIVEN TO FLOTEC INC BY FDA, FLOTEC WILL PRESENT ITS "BEST JUDGEMENT" VERSION OF WHAT HAS HAPPENED DURING THIS EVENT. WITH THE VERY SMALL AMOUNT OF INFO PROVIDED TO FLOTEC, AND WITH NO FURTHER INFO AVAILABLE TO FLOTEC, THIS IS FLOTEC'S "BEST JUDGEMENT" VERSION OF THE EVENT, THIS APPEARS TO BE A CLASSIC CASE OF WHERE THE CAREGIVER HAS ADULTERATED THE REGULATOR BY USING A NON-APPROVED YOKE WASHER SEAL WHEN THE REGULATOR WAS PLACED ONTO THE NEW, OR FULL CYLINDER, IF THIS WAS THE CASE, IT MAY HAVE CONTRIBUTED TO, OR CAUSED THE BRIEF FIRE FLASH. FLOTEC HAS BEEN IN THE FOREFRONT FOR MANY YEARS INFORMING USERS OF "YOKE STYLE" REGULATORS THAT THEY SHOULD ONLY USE THE ORIGINAL EQUIPMENT MANUFACTURERS RECOMMENDED "YOKE WASHER SEAL". FLOTEC'S "INFO FOR USE" INSERT INSTRUCTIONS MAKES REFERENCES TO THIS VERY ISSUE TWO DIFFERENT TIMES IN THE IFU, IT READS: WARNING: NEVER INSTALL A REGULATOR TO A POST-TYPE VALVE WITH MORE THAN ONE YOKE WASHER BETWEEN THE VALVE AND THE REGULATOR INLET. THE USE OF PLASTIC YOKE WASHER SEALS ON FLOTEC REGULATORS IS PROHIBITED. 18. DANGER: NEVER INSTALL A REGULATOR TO A POST-TYPE VALVE WITH MORE THAN ONE YOKE WASHER BETWEEN THE VALVE AND THE REGULATOR INLET. THE USE OF PLASTIC YOKE WASHER SEALS ON FLOTEC REGULATORS IS PROHIBITED. THIS INFO IN THE FORM OF THE "INFO FOR USE" INSERT INSTRUCTION IS PROVIDED WITH EACH UNIT SOLD, THIS SAME INFO IS AVAILABLE AT OUR WEB SITE WWW.FLOTECO2.COM. FLOTEC INC. ALSO HAS AN "OXYGEN REGULATOR SAFETY ALERT" POST ON OUR WEB SITE INFORMING PRODUCT USERS NOT TO REPLACE THE FACTORY INSTALLED DYNAMIC SEALS ON ANY FLOTEC OXYGEN REGULATOR WITH ANY NON-FLOTEC WASHERS OR SEALS. SEE ATTACHMENT: "A". ALSO IN OCTOBER OF 2005, FLOTEC INC. WAS SELECTED BY THE FDA, AND DID PARTICIPATE IN THE DEVELOPMENT AND FINALIZATION OF THE "FDA AND NIOSH PUBLIC HEALTH NOTIFICATION: OXYGEN REGULATOR FIRES RESULTING FROM INCORRECT USE OF CGA 870 SEALS. (SEE ATTACHMENT: "B"). THIS NOTIFICATION CLEARLY ILLUSTRATES THE DANGERS OF USING THE "NON-APPROVED" YOKE WASHER SEALS ON OXYGEN REGULATORS.

    Description of Event or Problem · 1

    ACCORDING TO A MAUDE EVENT REPORT, A CAREGIVER OF PT, (PT'S HUSBAND) WAS REPLACING AN EMPTY OXYGEN USP MEDICAL "E" STYLE CYLINDER WITH A NEW FULL CYLINDER. THE CAREGIVER ATTACHED THE REGULATOR TO THE NEW CYLINDER AND WHEN HE OPENED THE CYLINDER VALVE THERE WAS A BRIEF FIRE FLASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * REGULATOR CAN FLOTEC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1