BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1891211 · Received November 4, 2010

    Report

    Report Number
    2090040-2010-00014
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 24, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ASCENT
    Product Code
    NQG
    PMA / PMN Number
    K070034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS EVALUATED AND IT WAS FOUND THAT DRIED ADHESIVE WAS BLOCKING THE MAJORITY OF THE TUBING CONNECTION HOLE CONTRIBUTING TO THE INSUFFICIENT SUCTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED DEVICE INDICATED THAT THE STABILIZER PASSED ALL APPLICABLE TESTS AND INSPECTIONS PRIOR TO RELEASE. ASCENT HAS PROCEDURES IN PLACE TO PREVENT THE ADHESIVE FROM BLOCKING THE CONNECTION. THESE PROCEDURES ARE BEING REVIEWED TO ACCESS SUITABILITY. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY BYPASS PROCEDURE THE VACUUM STABILIZER'S SUCTION STOPPED WORKING. ANOTHER DEVICE WAS RETRIEVED TO COMPLETE THE PROCEDURE AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NQG NQG ASCENT OM-9000S 841720SH

    Patients

    Seq Age Sex Outcome Treatment
    1