BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSORMEDICS

    MDR report key: 1426171 · Received July 28, 2009

    Report

    Report Number
    2021710-2009-00026
    Event Type
    Other
    Date Received
    July 28, 2009
    Date of Event
    June 30, 2009
    Report Date
    July 29, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CARDINAL HEALTH SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PATIENT. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURE. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. RESULTS: O2 AND AIR FITTINGS WERE INCORRECTLY CONNECTED. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CARDINAL HEALTH FIELD SERVICE REP. THE CARDINAL HEALTH FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND IDENTIFIED THAT THE O2 AND AIR FITTINGS WERE INCORRECTLY CONNECTED. THE O2 FITTING WAS CONNECTED TO THE DEVICE AIR INPUT AND THE AIR FITTING WAS CONNECTED TO THE O2 DEVICE INPUT. THIS CAUSED THE O2 HOSE AND AIR HOSE TO BE CONNECTED INCORRECTLY. CARDINAL HEALTHY HAS BEEN UNABLE TO DETERMINE HOW THESE FITTINGS GOT CROSSED. IN ADDITION THE CARDINAL HEALTH FIELD SERVICE ENGINEER VERIFIED THAT THE DEVICE RAN FOR ABOUT 70 HOURS AFTER THE LAST PM PERFORMED BY CARDINAL HEALTH IN 2009. THE O2 AND AIR INPUT ON THIS DEVICE ARE CLEARLY LABELED AS SUCH AND HAD AN O2 ANALYZER BEEN USED AS PER OUR LABELING THE END USER WOULD HAVE IDENTIFIED THE O2 INACCURACY. THE CARDINAL HEALTH FIELD SERVICE ENGINEER SWITCHED THE FITTINGS AND HOSES TO THE CORRECT CONFIGURATION AND RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION THE DEVICE WAS RETURNED TO THE CUSTOMER READY FOR PATIENT USE. NO COMPONENT AND SYMPTOM TREND HAS BEEN IDENTIFIED AND THIS EVENT IS CONSIDERED TO BE AN ISOLATED INCIDENT.

    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 REPRESENTATIVE. "[NAME REMOVED] CALLED TO REPORT AN INCIDENT WHICH OCCURRED ON A PATIENT. COMPLAINT: PATIENT WAS PLACED ON THE 3100A AND AFTER 4 HOURS OF TRYING TO STABILIZE THE INFANT, THEY TOOK THE BABY OFF AND SWITCHED TO ANOTHER VENT. UPON EVALUATION, THEY FOUND THAT SOMEONE HAD SWITCHED THE O2 AND AIR HOSES COMING FROM THE BACK OF THE VENT (WATERTRAP CONNECTORS WERE MODIFIED/TEFLON TAPE APPLIED). I EXPLAINED TO HIM THAT WHEN THE VENT WAS SET UP, THE RTS SHOULD HAVE NOTICED THE MISCONFIGURED HOSES. THEY SHOULD HAVE NOTICED THE PROBLEM ALSO IF THEY HAD AN EXTERNAL OXYGEN ANALYZER IN-LINE. HE REALIZES THIS SO THIS IS WHY HE JUST WISHES TO DISCUSS THIS WITH [NAME REMOVED]."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK