BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY-FLEX 6' CPAP TUBING

    MDR report key: 6189642 · Received December 20, 2016

    Report

    Report Number
    3012316249-2016-00015
    Event Type
    Injury
    Date Received
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    WORLDCROSS INDUSTRIES CO., LTD.
    Product Code
    GAZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER SAID THE END-USER HAD THE CPAP TUBING HOOKED UP TO A VENTILATOR - THE PATIENT/END-USER'S SON WALKED INTO HIS BEDROOM AND NOTICED THAT HIS DAD (THE END-USER) WAS LETHARGIC AND TURNING BLUE, WITH NO RESPONSE FROM HIS DAD. THE SON NOTICED THAT THE END-USER (HIS DAD) WAS NOT GETTING ANY AIR FROM THE TUBING, AS IT HAD COLLAPSED, SO HE SWITCHED IT OUT WITH NEW TUBING AND THEN HIS DAD STARTED TO BECOME MORE RESPONSIVE. THE END-USER'S FAMILY CALLED OUR CUSTOMER THE NEXT MORNING TO EXPLAIN THE INCIDENT, AND SAID THE DAD WAS BACK TO HOW HE NORMALLY IS. COMPASS HEALTH BRANDS CUSTOMER SERVICE REPRESENTATIVE CALLED THE CUSTOMER TO EXPLAIN THAT CPAP TUBING SHOULD NOT BE USED ON VENTILATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842023 EASY-FLEX 6' CPAP TUBING CPAP TUBING GAZ WORLDCROSS INDUSTRIES CO., LTD. EASY-FLEX6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other