BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 1365276 · Received April 14, 2009

    Report

    Report Number
    1217052-2009-00020
    Event Type
    Injury
    Date Received
    April 14, 2009
    Date of Event
    March 18, 2009
    Report Date
    March 23, 2009
    Manufacturer
    GALEMED CORPORATION
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATIONS: (OTHER) SMITHS MEDICAL IS UNABLE TO PERFORM A COMPLETE INVESTIGATION AS THE USER FACILITY DID NOT RETAIN THE EVENT SAMPLE OR RECORD THE LOT NUMBER OF THE DEVICE BEING USED. WE HAVE NOTIFIED THE SUPPLIER OF THIS EVENT. A FIVE YEAR REVIEW OF OUR COMPLAINTS DATABASE SHOW NO SIMILAR REPORTS RECEIVED FOR THIS ISSUE. THIS REPORT HAS BEEN LOGGED FOR TRENDING.

    Description of Event or Problem · 1

    HOSPITAL REPORTED ONE EVENT THAT STAFF FOUND PT HAD SELF EXTUBATED AND WAS HAVING DIFFICULTY BREATHING. ATTEMPTED TO BAG AND THE DIAPHRAGM OF CHECK VALVE HAD BECOME DISLODGED AND FALLEN INTO RESUSCITATOR BAG. NO POSITIVE PRESSURE VENTILATION WAS ACHIEVED. THE PT RETURNED TO BASELINE BUT WAS HYPOXIC DURING THE EPISODE. NO PERMANENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, ADULT 73 BTM - RESUSCITATOR, PULMONARY, MANUALLY-OPERATED, SINGLE-USE BTM GALEMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention