BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2250935 · Received September 8, 2011

    Report

    Report Number
    2021710-2011-00069
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTS BY THE CAREFUSION FIELD SERVICE REP. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE AND DID NOT FIND ANY MOISTURE/WATER IN THE AIRWAY PRESSURE SENSE LINE AS WAS REPORTED. THE MOISTURE/WATER MAY HAVE DRIED OR BEEN BLOWN OUT WITH COMPRESSED AIR. THE CAREFUSION FIELD SERVICE REP RAN THE DEVICE WITH BOTH THE ORIGINAL PATIENT CIRCUIT AND A STANDARD 3100B PATIENT CIRCUIT WITH SIMILAR VALUES BEING DISPLAYED. THE CAREFUSION FIELD SERVICE REP CHECKED THE ZERO AND SPAN CALIBRATION OF THE PRESSURE TRANSDUCER AND FOUND THAT THE ZERO NEEDED A MINOR ADJUSTMENT. THE DEVICE WAS THEN RAN FOR SEVERAL HOURS TO ENSURE THAT IT WAS OPERATING PER MANUFACTURER'S SPECIFICATIONS. UNRELATED TO THE REPORTED EVENT THE CAREFUSION FIELD SERVICE REP DID FIND THAT THE "BATTERY LOW" LED WAS ON. THE CAREFUSION FIELD SERVICE REP REPLACED THE 9 VOLT BATTERY WHICH CORRECTED THIS ISSUE. ONCE THE EVALUATION WAS COMPLETED, THE DEVICE WAS RETURNED TO THE USER FACILITY'S CONTROL READY TO BE PLACED BACK INTO SERVICE. CAREFUSION HAS INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS VENTILATOR, HIGH FREQUENCY / LSZ LSZ CAREFUSION 3100B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA