BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXYGEN 1

    MDR report key: 2546108 · Received April 19, 2012

    Report

    Report Number
    3004550118-2012-00001
    Event Type
    Other
    Date Received
    April 19, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 15, 2012
    Manufacturer
    SHERWOOD VALVE LLC
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RECEIVED ON (B)(4) 2012, FOR EVAL. REPORTED EVENT DOES NOT MATCH THE TYPE OF PRODUCT RETURNED. THE EVENT DESCRIBES A QUICK DISCONNECT WHICH THE PART NUMBER (B)(4) DOES NOT INCLUDE. NO SERVICE RECORDS INDICATE SERIAL NUMBER WAS EVER RETURNED FOR MODIFICATION. CONCLUSION THAT A FIELD MODIFICATION OCCURRED WHICH IS NOT PERMITTED BY SHERWOOD. IF PRODUCT HAD QUICK DISCONNECT PRIOR REPORTS OF HANDLING DAMAGE AND ABUSE HAVE OCCURRED CAUSING SIMILAR EVENT. SHERWOOD PUBLISHED PRODUCT ADVISORY ON (B)(4) 2010. SHERWOOD PLANS NO FURTHER ACTION.

    Description of Event or Problem · 1

    EVENT DESC: REMOVING AMBU BAG FROM O2 TANK, WHEN A PORTION OF THE REGULATOR BROKE OFF AND BEGAN TO VENT THE TANK. DAMAGE TO QUICK CONNECT PORTION OF VALVE INCLUDING SPRINGS AND INTERNAL COMPONENTS WERE SHOT OFF TANK AND GRAZED RESPIRATORY THERAPY'S LEG (NO INJURY). WHAT WAS THE ORIGINAL INTENDED PROCEDURE? RESPIRATORY THERAPY ACRE. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G, BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN 1 REGULATOR, PRESSURE CAN SHERWOOD VALVE LLC VRAM5TVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other