BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCURY MEDICAL

    MDR report key: 2838991 · Received April 4, 2008

    Report

    Report Number
    1024404-2008-00001
    Event Type
    Injury
    Date Received
    April 4, 2008
    Date of Event
    March 11, 2008
    Report Date
    April 2, 2008
    Product Code
    BTM
    PMA / PMN Number
    K954866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    USER ERROR CAUSED EVENT. PRODUCT WAS NOT USED IN ACCORDANCE WITH INSTRUCTIONS FOR USE. AFTER INTUBATION THE HEALTH PROFESSIONAL DETACHED THE OXYGEN TUBING FROM THE UNIT AND INSERTED IT DIRECTLY INTO THE ENDOTRACHEAL (ET) TUBE. THIS RESULTED IN THE INFANT BILATERAL PTX REQUIRING BILATERAL CHEST TUBES. MERCURY MEDICAL HAS NO PREVIOUS RECORD OF THIS TYPE OF INCIDENT OCCURRING DATING BACK TO 1988.

    Description of Event or Problem · 1

    (B)(4). "OXYGEN CONNECTING TUBING WAS CONNECTED FROM A WALL FLOW METER TO A DISPOSABLE INFANT BMV DEVICE, THE CONNECTING TUBING WAS REMOVED FROM THE BVM DEVICE AND INADVERTENTLY ATTACHED TO THE END OF AN ET TUBE. THE CONNECTION WAS MADE DURING A RESUSCITATIVE EFFORT. THE INFANT DEVELOPED BILATERAL PTX REQUIRING BILATERAL CHEST TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCURY MEDICAL CPR BAG BTM 1055200 07324200

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Required Intervention