BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 438866 · Received January 23, 2003

    Report

    Report Number
    438866
    Event Type
    Other
    Date Received
    January 23, 2003
    Date of Event
    June 20, 2002
    Report Date
    July 30, 2002
    Manufacturer
    *
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH A DIAGNOSIS OF RESPIRATORY DISTRESS/ASTHMA NOTED TO BE DESATURATING WHILE ON WALL OXYGEN. SATURATIONS IMPROVED ON PORTABLE OXYGEN SOURCE. ANALYSIS OF WALL PORT LABELED "OXYGEN" WAS DELIVERING COMPRESSED AIR. THE MEDICAL AIR AND OXYGEN OUTLETS INSTALLED IN THE HOSP CONSIST OF SEVERAL PLATES, SCREWS, TABS, ETC. WHICH ARE INTERCHANGEABLE IN ASSEMBLY. THE ONLY DIFFERENCE BETWEEN THE TWO SYSTEMS AT THE OUTLET ARE: 1. THE PLASTIC TABS WHICH ARE KEYED TO THE TWO TYPES OF REGULATORS (MEDICAL AIR AND OXYGEN). THEY HAVE DIFFERENT CUTOUTS AND ARE DIFFERENT COLORS (GREEN FOR O2, BLACK FOR AIR). 2. THE METAL MOUNTING PLATE HAS A LABEL THAT SAYS EITHER "OXYGEN" OR "AIR." THE BACKGROUND UNDER THE LETTERING IS COLOR CODED. 3. THERE IS A STICKER ON THE PIPE BEHIND THE GAS SOCKET IN THE WALL WHICH SAYS "OXYGEN" OR "AIR" AND IS COLOR CODED. IF TWO OUTLETS ARE DISASSEMBLED AT THE SAME TIME IT IS ENTIRELY POSSIBLE TO REASSEMBLE THE OUTLETS BACKWARDS UNLESS THE TECHNICIAN IS PAYING ATTENTION TO THE BANDED LABEL ON THE PIPE BEHIND THE GAS SOCKET. THE UNIT CO INSPECTED HAD THE BANDED LABEL COVERED WITH DUST AND WOULD BE POSSIBLE TO OVERLOOK UNLESS THE TECHNICIAN KNEW THAT THE BAND WAS THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * WALL PORTS FOR OXYGEN AND AIR CAN * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other