BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDLINE MASK

    MDR report key: 5453855 · Received February 23, 2016

    Report

    Report Number
    2246980-2015-00025
    Event Type
    Death
    Date Received
    February 23, 2016
    Date of Event
    February 2, 2015
    Report Date
    February 22, 2015
    Manufacturer
    VENTLAB LLC.
    Product Code
    BTM
    PMA / PMN Number
    K053466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT DURING A CODE THE MASK DID NOT PROVIDE A GOOD SEAL TO THE PATIENT'S FACE. THE NURSE SAID THAT SHE DID NOT HAVE TIME TO INSPECT THE MASK AFTER THE INCIDENT AND THAT IT WAS DISCARDED. SHE SAID THAT THE CRASH CARTS ARE INSPECTED PER FACILITY POLICY. WHEN THE DIRECTOR OF NURSES MET WITH THE SALES REP. IT WAS NOT DETERMINED WHETHER THE RESUSCITATOR CAUSED THE PATIENT'S DEATH AND THE MASK SAMPLE HAD BEEN DISCARDED BY THE FACILITY SO NO INVESTIGATION COULD BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109910 MEDLINE MASK ADULT RESUS W/MASK AND BAG RESERVOIR BTM VENTLAB LLC. CORM1116 34587

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death