BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 TRAUMA FAST FLOW SYSTEMS - H-1200

    MDR report key: 7740912 · Received August 1, 2018

    Report

    Report Number
    3012307300-2018-03087
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Report Date
    September 12, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BSB
    UDI-DI
    50695085829506
    PMA / PMN Number
    BK020043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE LEVEL 1 TRAUMA FAST FLOW SYSTEMS - H-1200 WAS RECEIVED WITH TWO H-2 PRESSURE CUFFS SERIAL # (B)(4), IN GOOD CONDITION. THE MANUFACTURE DATE FOR THE DEVICE WAS 2009. THE DEVICE WAS POWERED ON, AND THE H-31B AIR DETECTOR CLAMP ALARM WAS ACTIVATED. THIS IMMEDIATELY CONFIRMED THE CUSTOMER'S REPORTED PROBLEM. TO ADDRESS THE ABOVE ISSUE, THE TECHNICIAN INSTALLED A NEW AIR DETECTOR BLOCK #4 SENSOR PART NUMBER 6040050 AND POWERED ON THE DEVICE. THE CLAMP ALARM DID NOT ACTIVATE, CONFIRMING ONCE AGAIN THAT A FAULTY SENSOR WAS IN FACT THE ISSUE. THE AIR DETECTOR SENSOR BOARD PART NUMBER 6040055 WAS ALSO REPLACED AS A PREVENTIVE MEASURE. AFTER THE ABOVE REPLACEMENTS WERE MADE, TEST DISPOSABLES WERE INSTALLED AND THE DEVICE WAS POWERED ON. ALL THE ALARM FUNCTIONS WERE TESTED AND PASSED. THE TEMPERATURE WAS MEASURED USING A TEMPCHECK E5993 DUE NOV 2018 AND IT WAS 41.7 DEGREES WHICH WAS WITHIN TOLERANCE. THE DEVICE WAS CONFIRMED TO PASS ALL FUNCTIONAL AND ELECTRICAL TESTS.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEVEL 1 TRAUMA FAST FLOW SYSTEMS (H-1200) GAVE A CLAMP ALARM, AND, DISPLAYED A RED LIGHT H-3 1B. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580435 LEVEL 1 TRAUMA FAST FLOW SYSTEMS - H-1200 WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION BSB SMITHS MEDICAL ASD, INC. H-1200 50695085829506

    Patients

    Seq Age Sex Outcome Treatment
    1