BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISON MEDICAL COLOR CODED FLOWMETER

    MDR report key: 230062 · Received June 25, 1999

    Report

    Report Number
    2523148-1999-00006
    Event Type
    Injury
    Date Received
    June 25, 1999
    Date of Event
    August 21, 1998
    Report Date
    June 23, 1999
    Manufacturer
    PRECISION MEDICAL INC.
    Product Code
    BXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PRELIMINARY INVESTIGATION INDICATES THAT THE FLOWMETER WAS USED IN CONJUNCTION WITH A LIQUID OXYGEN SYSTEM IN A NURSING HOME SETTING. DURING TREATMENT AT THE NURSING HOME, THE FLOW RATE WAS APPARENTLY AND WITHOUT AUTHORIZATION RESET TO A LEVEL THAT ALLOWED FOR OXYGEN FLOW IN EXCESS OF THE MEDICALLY PRESCRIBED FLOW RATE AND IN EXCESS OF A RATE WHICH COULD BE, OVER TIME ACCOMMODATED BY THE DESIGN OF THE OXYGEN DELIVERY SYSTEM. THE RESULTING DAMAGE WAS FROZED FACIAL TISSUE OF PT'S LIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISON MEDICAL COLOR CODED FLOWMETER 20 PSI, 8 LPM, FLOWMETER BXY PRECISION MEDICAL INC. 2MFA5008 0297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization