BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 1000

    MDR report key: 660869 · Received December 19, 2005

    Report

    Report Number
    MW1037460
    Event Type
    Injury
    Date Received
    December 19, 2005
    Date of Event
    September 29, 2005
    Report Date
    December 19, 2005
    Manufacturer
    PURITAN BENNETT CRYOGENIC DIVISION
    Product Code
    BYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S FACE WAS BURNED BY LIQUID OXYGEN WHILE USING A C1000 PORTABLE LIQUID OXYGEN UNIT. PT RESIDES IN A GROUP HOME WITH MULTIPLE CAREGIVERS. ONE REPORT FROM THE GROUP HOME INDICATED THAT THE PT WAS ROLLING AROUND ON THE FLOOR WHILE USING THE UNIT. ANOTHER EMPLOYEE REPORTED THAT THE PT WAS LEFT UNATTENDED AND THE LIQUID OXYGEN UNIT WAS TIPPED OVER ON ITS SIDE. PT HAD BEEN USING THE PORTABLE UNIT IN A BACKPACK -SCHOOL-TYPE; NOT MADE FOR USE WITH THE UNIT-. EQUIPMENT SERVICES SUPERVISOR RECEIVED AND INSPECTED THE C1000 THAT WAS USED DURING THE INCIDENT. HE FOUND THAT THE OUTER CASE WAS CRACKED AND SOME PIECES WERE RATTLING AROUND INSIDE THE UNIT. HE FILLED THE UNIT FROM A STATIONARY LIQUID OXYGEN UNIT, SET IT AT THE PRESCRIBED LITER FLOW, AND LET IT RUN FOR ABOUT AN HOUR. AFTER THAT TEST, THE CANNULA WAS ICE COLD AND STIFF AT ABOUT 12 INCHES FROM THE OUTLET, AND THERE WAS FROST ON THE OUTSIDE OF THE CASING. THE UNIT WAS SENT TO THE MANUFACTURER, TYCO HEALTHCARE/PURITAN BENNETT, FOR FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION 1000 PORTABLE LIQUID OXYGEN SYSTEM BYJ PURITAN BENNETT CRYOGENIC DIVISION C1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization