BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVS

    MDR report key: 2187293 · Received July 15, 2011

    Report

    Report Number
    9610531-2011-00001
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 18, 2011
    Report Date
    July 15, 2011
    Manufacturer
    PENLON LTD.
    Product Code
    CBK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE EXECUTIVE VICE PRESIDENT OF (B)(6) HOSPITAL REPORTED ON (B)(6) 2011 THAT ON (B)(6) 2011 THE AVS VENTILATOR (B)(4) FAILED DURING A KNEE OPERATION, WHILST IN USE ON A PATIENT. THE REPORT STATED THAT THE AVS SCREEN STARTED FLICKERING AND FROZE AND THE UNIT STOPPED VENTILATING. THERE WERE NO VISUAL OR AUDIBLE ALARMS AND THE PATIENT HAD TO BE VENTILATED MANUALLY. THE AVS VENTILATOR HAS BEEN REQUESTED FOR INVESTIGATION AND A REPLACEMENT VENTILATOR IS DUE TO BE SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVS CONTINUOUS VENTILATOR CBK PENLON LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other