BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1217052-2005-00056

    MDR report key: 743833 · Received July 15, 2005

    Report

    Report Number
    1217052-2005-00056
    Event Type
    Malfunction
    Date Received
    July 15, 2005
    Product Code
    BTM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    H.6 RESULTS EVAL CODES: WE ARE ANTICIPATING THE RETURN OF THE EVENT SAMPLE. IF THE SAMPE IS RETURNED THEN A FOLLOW-UP REPORT WILL BE SUBMITTED. SMITHS MEDICAL ASD, INC. HAS NOT REC'D ANY SIMILAR REPORTS ON THIS DEVICE LOT NUMBER OR ON ANY OF THIS PRODUCT LINE. THE HOSP REPORTED THAT THE ANESTHESIOLOGIST HELD THE MASK FIRMLY ONTO THE PT'S FACE AND ALLEGEDLY TWO OF MASKS "POPPED" WHEN HELD FIRMLY IN PLACE. PT DEMISE, HOWEVER, FACILITY FEELS THIS REPORT HAD NO IMPACT TO PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BTM

    Patients

    Seq Age Sex Outcome Treatment
    1