BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

    MDR report key: 9128932 · Received September 27, 2019

    Report

    Report Number
    9128932
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    June 9, 2019
    Report Date
    August 30, 2019
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROCEDURE (IVF RETRIEVAL) STARTED, SURGEON TESTED ASPIRATOR USING THE FOOT PEDAL, FOOT PEDAL WAS NOT ABLE TO MAINTAIN SUCTION. THE SURGICAL TEAM ATTEMPTED TO RECTIFY THE PROBLEM COUPLE OF TIMES BUT THE SUCTION WOULD NOT HOLD PRESSURE, WITH NO AVAIL WE NEEDED TO CONTACT CLINICAL ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923419 APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX ROCKET MEDICAL PLC R33-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 13140 DA