BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2063373 · Received February 10, 2011

    Report

    Report Number
    2021710-2011-00009
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    May 17, 2010
    Report Date
    May 17, 2010
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). "PERFORMANCE CHECKS CONDUCTED BUT ERROR WAS NOT DUPLICATED." NOTE: THE TYPE OF FAILURE REPORTED BY THE USER FACILITY IS TYPICALLY CAUSED BY A LOSS OF PRESSURE IN THE PT CIRCUIT DUE TO A LEAK. ONCE THE LEAK IS ELIMINATED, THE PT CIRCUIT WILL RE-PRESSURIZE AND THE DEVICE WILL RESUME OSCILLATION WHEN THE 'START/STOP' BUTTON IS PRESSED. AS THE USER FACILITY WAS UNABLE TO DUPLICATE THE REPORTED EVENT AND DID NOT FIND ANY PROBLEMS WITH THE DEVICE, CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT. SENSOR-MEDICS HIGH FREQUENCY OSCILLATORY VENTILATOR. CAREFUSION.

    Description of Event or Problem · 1

    (B)(4). "OSCILLATING NEONATAL VENT CEASED CIRCULATING AIR DUE TO LOSS OF PRESSURE WHILE IN USE ON PT. ALARM SOUNDED APPROPRIATELY AND STAFF PERFORMED MANUAL BAGGING WHILE EXCHANGING VENTILATOR. PERFORMANCE CHECKS CONDUCTED BUT ERROR WAS NOT DUPLICATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS VENTILATOR, HIGH FREQUENCY / LSZ LSZ CAREFUSION 3100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Required Intervention ASKU