BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIGH FREQUENCY OSCILLATORY VENTILATOR

    MDR report key: 602036 · Received June 24, 2004

    Report

    Report Number
    2050001-2004-00020
    Event Type
    Other
    Date Received
    June 24, 2004
    Date of Event
    June 1, 2004
    Report Date
    June 24, 2004
    Manufacturer
    SENSORMEDICS
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR WAS ON A VERY SICK PATIENT AND THE BELLOWS/WATERTRAP WAS NOT DRAINING. RT MADE CALL TO SENSORMEDICS CUSTOMER CARE, WHO RECOMMENDED THAT THE BELLOWS/ WATERTRAP BE REMOVED FROM THE VENTILATOR AND RE-PLACED WITH ANOTHER BELLOWS/WATERTRAP. RGA WAS ISSUED FOR THE RETURN OF THE DEFECTIVE BELLOWS/WATER-TRAP. THERE WAS NO PATIENT COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FREQUENCY OSCILLATORY VENTILATOR NEONATAL/PEDIATRIC VENTILATOR LSZ SENSORMEDICS 3100A *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other