BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1761636 · Received July 19, 2010

    Report

    Report Number
    2090040-2010-00004
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    June 18, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NQG
    PMA / PMN Number
    K070034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS EVALUATED AND IT WAS FOUND THAT WHEN THE DEVICE KNOB WAS TIGHTENED, THE BASE WAS LOOSE. THE SUCTION CAPABILITIES WERE NOT EXAMINED SINCE THIS MODEL DOES NOT POSSESS SUCTION CAPABILITIES. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED DEVICE INDICATED THAT THE STABILIZER PASSED ALL APPLICABLE TESTS AND INSPECTIONS PRIOR TO RELEASE, INCLUDING A MECHANICAL TEST ON THE ARM TO DETERMINE DISPLACEMENT WHEN FORCE IS APPLIED TO THE ARM. THIS IS THE FIRST COMPLAINT THAT ASCENT HAS RECEIVED FOR THE STABILIZER NOT LOCKING IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE CARDIAC STABILIZATION DEVICE LOST SUCTION AND THE HEART SLIPPED OFF. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NQG NQG ASCENT HEALTHCARE SOLUTIONS OM-2001S

    Patients

    Seq Age Sex Outcome Treatment
    1