BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2918643 · Received December 18, 2012

    Report

    Report Number
    2918643
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    October 16, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ALLIED HEALTH CARE PRODUCTS, INC.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ROBOTIC MVR BEING PUMPED IN PREPARATION FOR PROCEDURE. SURGEON REQUESTED VACUUM SET AT -40MMHG. LATER IN THE CASE, ATTEMPTED TO REDUCE VACUUM TO -30MMHGR. UNABLE TO MAINTAIN CONSTANT PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * REGULATOR, VACUUM GCX ALLIED HEALTH CARE PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR