BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITOR,ADULT

    MDR report key: 551804 · Received April 23, 2004

    Report

    Report Number
    1217052-2004-00032
    Event Type
    Malfunction
    Date Received
    April 23, 2004
    Date of Event
    April 6, 2004
    Report Date
    April 7, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC., BY GALE MED CORPORATION
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGES THAT THEY COULD NOT FIT THE FACE MASK TO THE RESUSCITATOR AS IT WAS MISSING THE WHITE SUPPORT COLLAR AND HAD BECOME MIS-SHAPEN. A SECOND RESUSCITATOR WAS OBTAINED AND THE MASK WAS DROPPED ON THE FLOOR. BEFORE A THIRD RESUSCITATOR WAS OBTAIN THE PATIENT WAS INTUBATED. NO ADVERSE OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITOR,ADULT MANUAL RESUSCITATOR SYSTEM BTM SMITHS MEDICAL ASD, INC., BY GALE MED CORPORATION NA 031006

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention