BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR-MEDICS HIGH FREQUENCY OSCILLATORY VENTILATOR

    MDR report key: 1950851 · Received December 30, 2010

    Report

    Report Number
    MW5018825
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    May 17, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    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 SENSOR-MEDICS HIGH FREQUENCY OSCILLATORY VENTILATOR CBK CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Required Intervention