BEUDAMED
    FDA Adverse Event Death Summary report: N

    ISU MODEL

    MDR report key: 6593537 · Received May 26, 2017

    Report

    Report Number
    6593537
    Event Type
    Death
    Date Received
    May 26, 2017
    Date of Event
    May 18, 2017
    Report Date
    May 24, 2017
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    KDP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REGULATOR DID NOT WORKED IN CODE. PORTABLE SUCTION USED WHILE SECOND SETUP WAS COMPLETED DURING CODE. MAINTENANCE CAME TO (ROOM OF CODE) AND CHECKED HEADWALL SUCTION. FOUND TO BE WORKING PROPERLY. MAINTENANCE SAID THAT PRESSURES AT THE WALL CHECKED OK. TOOK REGULATOR AND TESTED IT IN ROOM. PLUGGED IN, AND TURNED PRESSURE KNOB TO "ON" AND RAN PRESSURE UP THROUGH ENTIRE RANGE TO "HIGH" AND BACK DOWN. PASSED OPERATIONAL CHECK. RETURNED GAUGE TO NURSE MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375721 ISU MODEL SUCTION REGULATOR KDP OHMEDA MEDICAL 6-1251

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death