BEUDAMED
    FDA Adverse Event Summary report: N

    LINDE INTEGRATED VALVE (LIV)

    MDR report key: 4890661 · Received July 1, 2015

    Report

    Report Number
    3003900188-2015-00004
    Date Received
    July 1, 2015
    Date of Event
    June 4, 2015
    Report Date
    July 1, 2015
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVENT, NO PATIENT HARM, CYLINDER EXPECTED TO BE FULL DID NOT DELIVER GAS. VALVE UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THIS SPONTANEOUS MEDICAL DEVICE INCIDENT REPORT, FROM A CUSTOMER IN USA INVOLVES A CYLINDER LINDE INTEGRATED VALVE, LIV2. NO PATIENTS WERE INVOLVED. WHEN TO USE THE CYLINDER, IT WAS FOUND THAT THE CYLINDER WAS EMPTY AND THAT NOTHING CAME OUT. THE GAUGE SHOWED FULL. THERE WERE NO OBVIOUS DAMAGE TO THE OUTSIDE OF THE DEVICE (GUARD AND CYLINDER). DEVICE AWAITING INVESTIGATION BY A LIFEGAS PLANT QUALIFIED TO EVALUATE. DETAILS OF THE CYLINDER INVOLVED: PRODUCT: LIV 2,000 PSI. CEODEUX LOT NUMBER: 201209 35. CEODEUX S/N: (B)(4). ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426395 LINDE INTEGRATED VALVE (LIV) NONE ECX LIV 2000 PSI 201209 35

    Patients

    Seq Age Sex Outcome Treatment
    1