BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VEEVO INTERMITTANT/CONTINUOUS 1500 SERIES

    MDR report key: 5871399 · Received August 12, 2016

    Report

    Report Number
    5871399
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    December 21, 2015
    Report Date
    July 5, 2016
    Manufacturer
    TENACORE HOLDINGS, INC.
    Product Code
    KDP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BIOMED WENT TO THE SURGICAL ICU TO INVESTIGATE THE CONTINUOUS/INTERMITTENT SUCTION REGULATORS. FOUND THE OHIO MEDICAL AND THE OHMEDA MEDICAL SUCTION REGULATORS TO BE WORKING PROPERLY, BUT THE TENACORE SUCTION REGULATORS TESTED DID NOT WORK IN THE INTERMITTENT MODE. BIOMED OPENED ONE OF THE BROKEN TENACORE SUCTION REGULATORS AND FOUND THE RUBBER GASKET WAS CRACKED CAUSING THE SUCTION GAUGE TO LOSE ITS INTERMITTENT FUNCTION. BIOMED CHECKED ALL TENACORE SUCTION REGULATORS IN THE WHOLE MEDICAL CENTER AND FOUND SEVERAL WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525008 VEEVO INTERMITTANT/CONTINUOUS 1500 SERIES REGULATOR, VACUUM - TENACORE VACUUM REGULATOR KDP TENACORE HOLDINGS, INC. TWSA1500

    Patients

    Seq Age Sex Outcome Treatment
    1