BEUDAMED
    FDA Adverse Event Other Summary report: N

    VACCUUM REGULATOR

    MDR report key: 646617 · Received November 2, 2005

    Report

    Report Number
    646617
    Event Type
    Other
    Date Received
    November 2, 2005
    Date of Event
    October 29, 2005
    Report Date
    November 2, 2005
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    KDQ
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SUCTION DEVICE POPPED OFF THE WALL OUTLET HITTING THE PATIENT ON THE FOREHEAD. THE PATIENT SUSTAINED A SMALL NAIL SIZED CUT WITH MINOR BLEEDING AND DRESSING APPLIED. NO OTHER ADVERSE OUTCOME TO PATIENT. AFTER INSPECTION OF THE DEVICE BY THE RESPIRATORY THERAPIST, THE DEVICE WAS FINE AND IT IS THOUGHT THAT THE DEVICE WAS NOT FULLY SEATED IN THE OUTLET. THE WALL OUTLET AND PRESSURE WAS CHECKED AN IT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACCUUM REGULATOR SUCTION CONTAINER KDQ OHMEDA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *