BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRST BREATH ADULT THREE IN ONE MASK WITH RESERVOIR BAG

    MDR report key: 1289933 · Received January 16, 2009

    Report

    Report Number
    9610530-2009-00003
    Event Type
    Injury
    Date Received
    January 16, 2009
    Date of Event
    December 1, 2008
    Report Date
    December 19, 2008
    Manufacturer
    UNO MEDICAL FOR SMITHS MEDICAL ASD, INC.
    Product Code
    BYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATION CODES - SMITHS MEDICAL'S INVESTIGATION INTO THIS REPORT IS LIMITED AS THE COMPLAINT SAMPLE WAS NOT RETAINED. INVESTIGATION IS LIMITED TO THE FOLLOWING SOURCES OF INFORMATION: THE COMPLAINT INCIDENT REPORT FORM. COMPLAINTS HISTORY FOR THIS PRODUCT. A REVIEW OF OUR COMPLAINTS HISTORY CONFIRMED THIS TO BE THE FIRST COMPLAINT FOR THIS PRODUCT LOT. THOUGHT THERE HAVE BEEN TWO SIMILAR COMPLAINTS FOR DISCONNECT DURING THE PAST FIVE YEARS, THESE ARE HISTORICAL AND DO NOT INDICATE A SYSTEMATIC FAILURE DURING MANUFACTURE. IN THE ABSENCE OF THE COMPLAINT SAMPLE, WE WERE UNABLE TO FURTHER INVESTIGATE THIS INCIDENT AND CAN ONLY SURMISE THIS INCIDENT IS RELATED TO EITHER OF THE FOLLOWING: THE DEGREE OF RETENTION BETWEEN THE TUBE AND CONNECTOR WAS LOWER THAN USUAL. THE USER INADVERTENTLY CAUSED THE DETACHMENT DURING MOVEMENT. THOUGH WE ARE SYMPATHETIC TO THE UNFORTUNATE OUTCOME IN THIS INCIDENT, THERE IS NO EVIDENCE TO INDICATE THIS PRODUCT FAILED AS A RESULT OF MANUFACTURING DEFECT. THIS REPORT HAS BEEN LOGGED FOR TRENDING.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE WAS NOTIFIED OF AN EVENT THAT THE HOSPITAL REPORTED THEY HAD THE OXYGEN MASK PRESSED TO THE PATIENTS FACE. A FEW DAYS LATER, THE OXYGEN TUBE DETACHED FROM THE MASK. THEY REATTACHED THE TUBE AGAIN, HOWEVER, THE PATIENT DIED. THE HOSPITAL FEELS THAT THE DEATH WAS CAUSED BY THE PATIENT'S CONDITION, AND NOT A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST BREATH ADULT THREE IN ONE MASK WITH RESERVOIR BAG 73 BYG - MASK, AIR/OXYGEN BYG UNO MEDICAL FOR SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention