BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SODASORB

    MDR report key: 1822960 · Received August 12, 2010

    Report

    Report Number
    1822960
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 12, 2010
    Manufacturer
    W.R. GRACE AND COMPANY
    Product Code
    CBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE SODA-LIME CANNISTER ISSUE. RECEIVED CALL FROM ANESTHESIA TECH. SHE SAID THE ANESTHESIOLOGIST WAS NOT ABLE TO VENTILATE THE PATIENT IN OR AND THEY HAD TO SWITCH OUT THE ANESTHESIA MACHINE WITH ONE FROM ANOTHER OR. I CHECKED THE MACHINE AND FOUND ONE OF THE SODA-LIME PACKS TO BE THE PROBLEM, IT DID NOT HAVE ANY HOLES IN THE BOTTOM OF IF TO ALLOW FLOW THROUGH IT. AESTIVA ANESTHESIA MACHINE.HEALTH PROFESSIONAL'S IMPRESSION:VISUALLY SEE THE HOLES INTENDED TO BE ON THE BOTTOM OF THE FILTER HAD NOT BEEN CUT OUT OF THE PLASTIC. MANUFACTURING FLAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SODASORB ABSORBENT, CARBON-DIOXIDE CBL W.R. GRACE AND COMPANY LF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR