BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCEAN DRAIN

    MDR report key: 6092266 · Received November 10, 2016

    Report

    Report Number
    6092266
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    August 15, 2016
    Report Date
    September 27, 2016
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED LARGER PNEUMOTHORAX AFTER TAKING OFF SUCTION TO WATER SEAL. PER PA THERE SHOULD BE NO REASON FOR INCREASE IN PNEUMOTHORAX SIZE AND IS SEEING THIS MORE FREQUENTLY WITH NEW PLEURA VACS. PA CHECKS SET-UP OF CHEST TUBE TO CHECK FOR HUMAN ERROR AFTER REALIZING A TREND ON PNEUMO FROM WATER SEAL TO SUCTION. MANUFACTURER RESPONSE FOR OCEAN PLEURA VAC, ATRIUM OCEAN (PER SITE REPORTER): VENDOR REP AT OUR FACILITY HAS BEEN NOTIFIED OF ISSUE. INFORMATION TAKEN > NO FURTHER RESPONSE FROM THEM. WE ARE MONITORING THE DEVICES MORE CLOSELY. STAFF AWARE OF ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745107 OCEAN DRAIN BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other