BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSORMEDICS

    MDR report key: 1482855 · Received September 18, 2009

    Report

    Report Number
    2021710-2009-00037
    Event Type
    Other
    Date Received
    September 18, 2009
    Date of Event
    July 11, 2009
    Report Date
    September 17, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4): RESULTS - MAP PRESSURE ADJUSTMENT KNOB TURNED PAST THE STOP POINT. THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE EVALUATIONS PERFORMED BY THE CARDINAL HEALTH FIELD SERVICE REP. THE CARDINAL HEALTH FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND IDENTIFIED A USER ERROR AS THE ROOT CAUSE IN THIS EVENT. THE END USER TURNED THE MAP PRESSURE ADJUSTMENT KNOB PAST THE STOP POINT, CAUSING THE ADJUSTMENT TO GO OUT OF SPEC AND DEVICE LOOSING PRESSURE. THE CARDINAL HEALTH FIELD SERVICE ENGINEER ADJUSTED THE MAP PRESSURE ADJUSTMENT KNOB TO THE CORRECT POSITON BY REMOVING THE COLLECT KNOB (B) (4) AND POINTER KNOB (B) (4), AND TURNING THE NEEDLE VALVE (B) (4) TO THE FAR RIGHT AND THEN INSTALLING A NEW COLLECT KNOB AND POINTER KNOB. HE THEN RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE. A REVIEW OF TRENDED COMPLAINTS FOR THE PASS 6 MONTHS DOES NOT REVEAL A TREND ASSOCIATED WITH THE MAP PRESSURE ADJUSTMENT KNOB, AT PRESENT THIS EVENT IS CONSIDERED TO BE AN ISOLATED INCIDENT. ADDITIONALLY, THIS FILE WILL BE TRENDED AS PART OF OUR MONTHLY TRENDED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. ON (B) (6) 2009: "[NAME REMOVED] WOULD LIKE A SERVICE CALL ON THIS UNIT. HE CAN'T GET THE CIRCUIT TO PRESSURIZE AT ALL. HE HAS TRIED THE SAME CIRCUIT ON ANOTHER UNIT AND IT WORKS FINE. HE DID NOT HAVE THE HOURS ON THE UNIT AT THIS TIME". THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CARDINAL HEALTH (B) (4) FROM THE FDA AND THEN FORWARDED TO CARDINAL HEALTH 2007, INC ON (B) (6) 2009. "EVENT DESC: PT DESATTING, DID A RECRUITMENT MANEUVER. WENT WELL. STANDING AT BEDSIDE WATCHING MONITOR AND HFOV DEPRESSURIZED AND TRIED TO REPRESSURIZE ONCE. THEN STOPPED. TOOK 2-3 MINUTES TO GET THE MACHINE WORKING AGAIN. WAS THEN SWITCHED OUT FOR ANOTHER A FEW HOURS LATER." "MFR RESPONSE (AS PER REPORTER) FOR VENTILATOR, HIGH FREQ VENTILATOR". "CAREFUSION FIELD SERVICE (FS) TECH IN ONE WEEK LATER AND REPLACED PRESSURE ADJUST KNOB ASSEMBLY. FS TECH COMPLETED CIRCUIT AND PERFORMANCE CHECKS AND VALIDATED UNIT READY FOR PT USE". "DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T' GET IT TO WORK OR STOPPED WORKING)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73LSZ, VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC. 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other