BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2669664 · Received July 10, 2012

    Report

    Report Number
    2021710-2012-00067
    Event Type
    Malfunction
    Date Received
    July 10, 2012
    Date of Event
    May 4, 2012
    Report Date
    May 4, 2012
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT PROVIDE ANY PT OR DEVICE CODES ON THEIR USER FACILITY REPORT. THE USER FACILITY MEDWATCH REPORT RECEIVED FROM THE FDA ON JUNE 25, 2012 AND INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST ON JUNE 12, 2012 IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. (B)(4). THE FOLLOWING DESCRIPTION OF THE DEVICE EVALUATION BY THE USER FACILITY WAS COPIED OFF THE USER FACILITY MEDWATCH REPORT RECEIVED FROM THE FDA ON JUNE 25, 2012. ¿TESTED UNIT, PERFORMED 2500HR CAL, PM, ON (B)(4)2012: TESTED UNIT AND FOUND EXCESSIVE MOISTURE IN PT CIRCUIT. CHANGED CIRCUIT AND PERFORMED CIRCUIT CALIBRATION AND NO OTHER PROBLEM WAS FOUND. ALL TESTS PASSED PER OEM SPECS.¿ THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE CAREFUSION FIELD SERVICE REP. EVALUATED THE DEVICE ON JUNE 18, 2012 AND WAS UNABLE TO REPRODUCE/VERIFY THE REPORTED EVENT. THUS NO ROOT CAUSE WAS DETERMINED. THE CAREFUSION FIELD SERVICE REP RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO VERIFY OPERATION OF THE DEVICE TO INCLUDE VERIFYING THAT THE DEVICE¿S AUDIBLE AND VISUAL ALARMS FUNCTION PROPERLY. ONCE THIS WAS COMPLETED THE DEVICE WAS RETURNED TO THE USER FACILITY¿S CONTROL READY TO BE PLACED BACK INTO SERVICE. NO COMPONENT OR SYSTEM TREND HAS BEEN IDENTIFIED. THUS CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED ON JUNE 12, 2012 BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. [NAME REMOVED] CALLED AND SAID THAT THEY WANT A SVC CALL ON THIS UNIT. THEY WANT A FIELD REP FROM CAREFUSION TO LOOK AT IT. SHE SAID THAT THE PROBLEM WITH THE UNIT IS FLUCTUATING MAP. SHE DIDN'T HAVE SPECIFIC NUMBERS, JUST THAT IT FLUCTUATES. THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CAREFUSION FROM THE FDA ON JUNE 25, 2012. EVENT DESCRIPTION: THE MEAN AIRWAY PRESSURE SETTING WAS FLUCTUATING AND THEN STARTED READING 1.5 CM H2O. ALARMS NEVER WENT OFF FOR LOW MEAN AIRWAY PRESSURE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? PT VENTILATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO