BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGEN & AEROSOL THERAPY

    MDR report key: 3904664 · Received June 30, 2014

    Report

    Report Number
    9680866-2014-00007
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 27, 2014
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    BYG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION THIS EVENT IS DEEMED A DEATH. ADDITIONAL FOLLOW-UP INFORMATION REGARDING PATIENT / EVENT DETAILS WAS REQUESTED ON (B)(6) 2014. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN NEED OF OXYGEN (15 LITERS PER MINUTE) AND DURING THE CHANGING HOURS FOR THE STAFF, THE PATIENT WAS FOUND DEAD, WITH THE OXYGEN MASK DISCONNECTED FROM THE OXYGEN TUBE (FROM FISCHER PAYKEL). THUS, THE PATIENT WAS IN LACK OF OXYGEN FOR AN UNKNOWN DURATION OF TIME AND FOUND DEAD, NO RESUSCITATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379647 OXYGEN & AEROSOL THERAPY MASK, OXYGEN BYG UNOMEDICAL S.A. DE C.V. UNK 99283

    Patients

    Seq Age Sex Outcome Treatment
    1 Death