BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, INFANT

    MDR report key: 1076966 · Received July 10, 2008

    Report

    Report Number
    1217052-2008-00092
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC., GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATIONS: THE SAMPLES HAVE BEEN FORWARDED TO THE MFR FOR INVESTIGATION. UPON RECEIPT OF THE COMPLETED INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. WE CAN REPORT THAT WE HAVE NOT RECEIVED ANY OTHER REPORTS ON THIS DEVICE LOT NUMBER.

    Description of Event or Problem · 1

    USER ALLEGES HAVING ONE EVENT WHERE THE MASKS WERE UNDERINFLATED. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, INFANT 73 BTM - RESUSCITATOR, PULMONARY, MANUALLY-OPERATED, SINGLE-USE BTM SMITHS MEDICAL ASD, INC., GALEMED CORPORATION R071029

    Patients

    Seq Age Sex Outcome Treatment
    1