BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL 700/ABL 800FLEX

    MDR report key: 1470454 · Received May 14, 2009

    Report

    Report Number
    3002807968-2009-00011
    Event Type
    Malfunction
    Date Received
    May 14, 2009
    Date of Event
    April 16, 2009
    Report Date
    April 16, 2009
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HEAVY WELD CAUSED CLOGGED VENT HOLES. THE FOLLOWING LOTS OF WASTE BOTTLES ARE AFFECTED: FOR 905-590/D512: WR-01, WR-02, WR-03, WR-04, WS-01, WS-02, WS-03, WU-01, WU-02, WU-03. FOR 905-802/D513: WR-01, WR-02, WR-03, WR-04, WS-01, WS-02, WS-03, WS-04, WU-01, WU-02, WU-03, WU-04, WU-05, WU-06, WY-01. MFG PERIOD: 01/06/2009 TO 04/06/2009.

    Description of Event or Problem · 1

    WHEN REMOVING THE WASTE BOTTLE FROM A BLOOD GAS ANALYZER, WASTE MATERIAL MAY LEAK BOTH FROM THE ANALYZER, AND FROM THE WASTE BOTTLE. USERS MAY BE EXPOSED TO THE BLOOD WASTE FROM THE BLOOD GAS ANALYZER. THERE HAVE BEEN NO ALLEGATIONS OF DEATH OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL 700/ABL 800FLEX BLOOD GAS ANALYZER CHL RADIOMETER MEDICAL APS D513 WR-01

    Patients

    Seq Age Sex Outcome Treatment
    1