BEUDAMED
    FDA Adverse Event Other Summary report: N

    H-1200/H-31B FAST FLOW FLUID WARMER

    MDR report key: 649255 · Received December 5, 2005

    Report

    Report Number
    1221261-2005-00030
    Event Type
    Other
    Date Received
    December 5, 2005
    Date of Event
    November 18, 2005
    Report Date
    December 5, 2005
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H.6 EVALUATION - METHOD AND CONCLUSION: THE UNIT WAS RETURNED TO SMITHS MEDICAL FOR EVALUATION. OUR ENGINEERING DEPARTMENT EVALUATED THIS UNIT AND WHEN THE UNIT WAS POWERED ON, IT WOULD GO INTO AN OFF/ON GREEN LED CYCLE CAUSING THE ERRONEOUS ALARMS. FURTHER EVALUATION REVEALED THAT THE THERMISTOR WAS SIGHTLY PULLED OUT OF POSITION ON THE PC BOARD, WHICH CAUSED AN INTERMITTENT CONNECTION. THE F5 FUSE COVER WAS LIFTED OFF OF THE FUSE AND THE C11 CAPACITOR ON THE BOARD WAS ALSO LIFTED FROM ITS NORMAL POSITION. IN ADDITION THE OUTER LEFT SIDE OF THE CABINET HAD A LARGE CRACK. CONCLUSION: THE ROOT CAUSE FOR ERRONEOUS ALARMS WAS DUE TO THE THERMISTOR BEING SLIGHTLY PULLED OUT OF POSITION ON THE PC BOARD. THE ROOT CAUSE FOR THE OUTER COMPONENTS ON THE BOARD BEING OUT OF POSITION IS INCONCLUSIVE. A REVIEW OF OUR INTERNAL TESTING DOCUMENTATION WAS REVIEWED AND THIS UNIT PASSED ALL MANUFACTURING AND QUALITY TESTING BEFORE LEAVING THE FACILITY. THE ROOT CAUSE FOR THE CABINET BEING CRACKED WAS DUE TO SHIPPING DAMAGE WHEN THE UNIT WAS TRANSPORTED BACK TO ROCKLAND. A NEW UNIT WAS SENT TO THE FACILITY AND THEY HAVE NOT HAD ANY ISSUES WITH THE UNIT.

    Description of Event or Problem · 1

    USER ALLEGES THAT DUE TO THE DESIGN OF THE AIR DETECTOR AND FILTER WITH GAS EVENT SENSOR, LEADS TO ERRONEOUS ALARMS, WHICH INTERFERRED WITH THE PROCESS OF PT RESUSCITATION AT A VERY CRITICAL TIME. MFR HAS HAD TO REPLACE THIS UNIT TWICE DURING THE COURSE OF A PT RESUSCITATION. THIS LEADS TO DELAYS AT A TIME WHEN THE PT COULD ILL AFFORD IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-1200/H-31B FAST FLOW FLUID WARMER FAST FLOW FLUID WARMER LGZ SMITHS MEDICAL ASD, INC. H-1200/H-31B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO