BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP TUBING

    MDR report key: 1604007 · Received December 9, 2009

    Report

    Report Number
    MW5014737
    Event Type
    Injury
    Date Received
    December 9, 2009
    Date of Event
    November 10, 2009
    Report Date
    December 9, 2009
    Manufacturer
    AG INDUSTRIES
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USE A CPAP BREATHING MACHINE WHEN I SLEEP DUE TO SLEEP APNEA. I ROUTINELY OBTAINED A REPLACEMENT CPAP AIR SUPPLY TUBE FROM MY LOCAL (B) (4) DEALER ON NOVEMBER 5, 2009. I EXPERIENCED A FAILURE OF THE NEW AIR SUPPLY HOSE A FEW DAYS LATER WHICH CUT OFF MY AIR SUPPLY DURING THE NIGHT. I AWOKE GASPING FOR AIR, UNABLE TO BREATHE. UPON EXAMINATION OF THE NEW AIR SUPPLY HOSE, I FOUND THAT THE INNER LINING OF THE HOSE HAD COME LOOSE AND CUT OFF THE AIR SUPPLY. THIS PROBLEM COULD CAUSE SERIOUS PROBLEMS, EVEN DEATH FOR SOME PEOPLE WHO RELY ON CPAP FOR THEIR MEDICAL CONDITIONS. I HAVE USED CPAP FOR SEVERAL YEARS WITHOUT ENCOUNTERING THIS PROBLEM BEFORE. WHEN I COMPARE MY OLDER AIR SUPPLY HOSES WITH THIS NEW ONE, IT APPEARS THAT THE NEW ONE THAT IS NOW BEING SUPPLIED BY (B) (4) IS NOT MADE TO THE SAME QUALITY STANDARDS AS THE OLDER HOSES WERE. THERE IS LESS SPIRAL WINDING AROUND THE HOSE, AND THEREFORE, LESS SUPPORT. THE HOSE LINER IS OF A THINNER MATERIAL, ALMOST CELLOPHANE LIKE, AND IT DELAMINATES FROM THE OUTER SPIRAL REINFORCEMENT TO THE POINT THAT IT CAN CHOKE OFF THE AIR SUPPLY, AS IT DID IN MY CASE. FOLLOWING IS THE INFO FROM THE BAG IN WHICH THE HOSE WAS SHIPPED: THE HOSE WAS MFG BY AG INDUSTRIES, (B) (4), PART NUMBER HCG72, LOT NUMBER 110209. I HAVE EXAMINED OTHER LOT NUMBERS AND IT APPEARS THAT ALL ARE MADE THE SAME WAY AND ALL ARE PRONE TO FAILURE, DUE TO DESIGN AND MFG FLAWS. THERE IS NO CERTIFICATION OR COMPLIANCE INFO WHATSOEVER ON THE BAG IN WHICH THE HOSE WAS SEALED. UPON EXAMINATION AND COMPARISON WITH PREVIOUS CPAP HOSES, IT IS OBVIOUS THAT THIS IS A MUCH MORE CHEAPLY MADE PRODUCT POSSIBLY FROM (B) (4)? AND THAT IT IS UNSAFE, UNCERTIFIED AND A DANGER TO THE PUBLIC. I BELIEVE THAT THIS PRODUCT SHOULD BE RECALLED. I PROMPTLY RETURNED THE DEFECTIVE PRODUCT TO MY LOCAL (B) (4) OFFICE AND IT WAS EXCHANGED FOR A DIFFERENT BRAND OF BETTER MANUFACTURE THAT CLEARLY SHOWS COMPLIANCE INFO ON THE PACKAGE. I WAS INFORMED THAT THERE HAD BEEN SOME OTHER CASES REPORTED OF THE AG INDUSTRIES HCG72 HOSE FAILURE. AT THIS TIME I STILL HAVE ONE OTHER UNOPENED AG INDUSTRIES HOSE IF YOU WISH TO TEST AND COMPARE THE QUALITY OF THE AG PRODUCT TO ONE THAT IS CERTIFIED AND COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPAP TUBING CPAP AIR SUPPLY HOSE BZD AG INDUSTRIES HCG72 110209
    2 CPAP TUBING CPAP AIR SUPPLY HOSE BZD AG INDUSTRIES HCG72 100509

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening