BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHMEDA INTERMITTENT SUCTION UNIT

    MDR report key: 2202194 · Received August 5, 2011

    Report

    Report Number
    MW5021681
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 5, 2011
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    KDP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN CHECKED REGULATOR ON SUCTIONING DEVICE PRIOR TO SUCTIONING INFANT. SETTING WAS TO BE NO HIGHER THAN 60. REGULATOR AT THAT TIME WAS AT THE CORRECT SETTING. RN BEGAN ETT SUCTIONING AND NOTICED BRIGHT RED BLOOD. SHE DISCONTINUED USE AND CHECKED THE SETTING ON THE SUCTION DEVICE AND DISCOVERED THAT THE SUCTIONING REGULATOR HAD JUMPED TO FULL VAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA INTERMITTENT SUCTION UNIT REGULATOR KDP OHMEDA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA Other