BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPONSE RESUSCITATOR ADULT

    MDR report key: 781673 · Received December 28, 2004

    Report

    Report Number
    1217052-2004-00094
    Event Type
    Malfunction
    Date Received
    December 28, 2004
    Date of Event
    June 1, 2004
    Report Date
    December 1, 2004
    Manufacturer
    ASD, INC. BY: GALEMED CORP
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6. RESULTS EVALUATION CODES: SMITHS MEDICAL ASD, INC. IS NOT ABLE TO FULLY EVALUATE THIS REPORT AS NO SAMPLES OR LOT NUMBERS ARE AVAILABLE FOR EVALUATION. IF THE FACE MASK WERE MISSING, IT WOULD BE VISIBLE THROUGH THE PACKAGE, AS THE PACKAGING FOR THIS DEVICE IS CLEAR, AND SHOULD HAVE BEEN NOTICED PRIOR TO USE. A SMITHS MEDICAL ASD, INC. SALES REP WENT TO THE HOSP TO AUDIT THEIR INVENTORY FOR MISSING MASKS. HE WAS TOLD THAT WOULD NOT BE NECESSARY AS THIS EVENT OCCURRED LAST SUMMER AND THEY WOULD NOT HAVE ANY OF THAT INVENTORY LEFT AND THEY HAVE NOT HAD ANY OTHER EVENTS.

    Description of Event or Problem · 1

    USER ALLEGES THAT A RESUSCITATOR WAS MISSING THE FACE MASK DURING A CODE SITUATION. ANOTHER UNIT WAS OBTAINED AND NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPONSE RESUSCITATOR ADULT MANUAL RESUSCITATOR SYSTEM BTM ASD, INC. BY: GALEMED CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO