BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O2 FLOW METER - FOR 15LPM OF FLOW

    MDR report key: 2004004 · Received February 25, 2011

    Report

    Report Number
    MW5019567
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 16, 2011
    Manufacturer
    PRECISION MEDICAL
    Product Code
    BZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE STAFF WERE ATTEMPTING TO BAG THE PT VIA MAPLESON, IT APPEARED THAT THE O2 FLOW WAS NOT CORRECT DESPITE THE FLOW METER BALL MOVING. DEVICE WAS MAKING A WHISTLE SOUND. DEVICE WAS REMOVED FROM SERVICE AND REPLACED WITH A NEW ONE. THE DEVICE HAS BEEN RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O2 FLOW METER - FOR 15LPM OF FLOW BZH PRECISION MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO