BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDOCS 120B-22

    MDR report key: 2498549 · Received February 18, 2012

    Report

    Report Number
    2032532-2012-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2012
    Date of Event
    January 17, 2012
    Report Date
    February 13, 2012
    Manufacturer
    PACIFIC CONSOLIDATED INDUSTRIES
    Product Code
    CAW
    PMA / PMN Number
    K061414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE COMPONENTS WERE REQUESTED TO BE RETURNED TO THE MANUFACTURER ON (B)(4) 2012, FOR INVESTIGATION. THE ARMY HAS MADE THE DECISION TO RETAIN THE UNIT AND CONDUCT THE ROOT CAUSE INVESTIGATION. PCI WILL ASSIST IN THE INVESTIGATION.

    Description of Event or Problem · 1

    AN IGNITION EVENT WAS EXPERIENCED ON AN EXPEDITIONARY DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS) (B)(4). THE USER WAS UTILIZING THE EDOCS TO FILL A HOSPITAL OXYGEN BACK-UP SYSTEM (HOBS). UPON CLOSING THE LAST VALVE ON THE HOBS, A LOUD BOOM WAS HEARD IN THE DIRECTION OF THE EDOCS. THE USER INSPECTED THE EDOCS TO FIND BLACK MARKS ON THE PANEL AT THE VENT SIDE OF THREE-WAY BALL VALVE V-8 (HP OXYGEN SUPPLY QD VENT V-8) AND BLACK STAINS AND A DIME-SIZED HOLE NEAR THE HANDLE OF VALVE V-8. THE IGNITION WAS EXPELLED FROM A VENT TUBE ATTACHED TO V-8 BEHIND THE USER INTERFACE PANEL LOCATED APPROXIMATELY THREE INCHES BELOW THE HOSE CONNECTION BETWEEN THE EDOCS QUICK DISCONNECT PORT. A HOSE WAS CONNECTED TO THE PORT AT THE TIME OF THE IGNITION EVENT AND V-8 WAS IN THE OPEN POSITION ALLOWING 2250 PSIG TO BE TRANSFERRED FROM THE EDOCS TO THE HOBS. THE EDOCS WAS NOT SUPPLYING OXYGEN TO A PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDOCS 120B-22 OXYGEN CONCENTRTOR CAW PACIFIC CONSOLIDATED INDUSTRIES EDOCS 120B-22

    Patients

    Seq Age Sex Outcome Treatment
    1