BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHMEDA

    MDR report key: 698809 · Received March 30, 2006

    Report

    Report Number
    MW1038379
    Event Type
    Injury
    Date Received
    March 30, 2006
    Date of Event
    March 20, 2006
    Report Date
    March 22, 2006
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    GCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WALL MOUNT SUCTION DEVICE AUTOMATICALLY SHUT-OFF INAPPROPRIATELY. PT ASPIRATED GASTRIC CONTENTS FOLLOWING DEVICE SHUT-OFF. PT VOMITED X2; O2 SATURATION DROPPED, FIO2 REQUIRED INCREASE FROM ROOM AIR TO 60%; CXR SHOWED INFILTRATES. THE PT HAS HAD A LARGE AMOUNT OF OUTPUT FROM HER NASOGASTRIC TUBE OVER THE PAST SEVERAL DAYS. AT 1715 THE PT VOMITED. ANOTHER NURSE WENT TO CHECK ON THE PT AND FOUND THE NASOGASTRIC TUBE WAS NOT TO SUCTION.THE NURSE READJUSTED THE WALL MOUNT SUCTION VENT TO APPLY LOW CONTINUOUS WALL SUCTION. AT 1730, PT VOMITED AGAIN. I WENT IN TO CHECK ON THE PT AND FOUND THE WALL MOUNT UNIT WAS NOT APPLYING SUCITON. I CALLED DR. TUBE FEEDINGS PER JEJUNOSTOMY TUBE WERE STOPPED. THE WALL MOUNT WAS CHANGED OUT WITH A NEW ONE. THE OLD WALL MOUNT WAS PLACED INTO ANOTHER SUCTION OUTLET AND FOUND TO APPLY LOW CONTINUOUS WALL SUCTION AND THEN AUTOMATICALLY SHUT OFF BY ITSELF. THE UNIT WAS LABELED AS NONFUNCTIONAL. THE NEW UNIT WAS PROBLEM-FREE THE FOLLOWING SHIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA WALL MOUNTED SUCTION DEVICE GCX OHMEDA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L