BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 1408837 · Received June 17, 2009

    Report

    Report Number
    2021710-2009-00020
    Event Type
    Malfunction
    Date Received
    June 17, 2009
    Date of Event
    April 28, 2009
    Report Date
    June 17, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    PMA / PMN Number
    K013642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE EVAL PERFORMED BY THE CARDINAL HEALTH FIELD SERVICE REP. THE CARDINAL HEALTH FIELD SERVICE REP WENT ON SITE TO EVALUATE THE DEVICE AND IDENTIFIED THAT THE ROOT CAUSE OF THE REPORTED FROZEN SCREEN WAS A FAULTY USER INTERFACE MODULE. HOWEVER, HE WAS NOT ABLE TO REPRODUCE THE REPORTED ALARM FAILURE, ALARMS OPERATED AS INTENDED. DURING THE EVAL THE FILED SERVICE REP IDENTIFIED A CONFIG LOST AND SETTING LOST ERROR CODES ON THE DEVICE ERROR LOG. THESE CODES OCCURRED IN 2009 WHICH IS AFTER THE REPORTED EVENT. BASED ON THE ERROR CODES THE FIELD SERVICE REP REPLACED THE GAS DELIVER ENGINE P/N 16222 AS A PRECAUTION. THE CARDINAL HEALTH FIELD SERVICE REP REPLACED THE USER INTERFACE MODULE, GAS DELIVER ENGINE 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 TO BE PLACED BACK INTO SERVICE. THE DEFECTIVE COMPONENTS HAVE NOT BEEN RETURNED BY CUSTOMER. A LETTER WAS SENT TO THE CUSTOMER NOTIFYING THEM THAT THE FAULTY COMPONENTS HAVE NOT BEEN RECEIVED AND REQUESTING THAT THE COMPONENTS TO BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTS BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. IN 2009: "THE CUSTOMER CALLED REQUESTING FSD SECONDARY TO THE UNIT'S DISPLAY IS NOT RESPONSIVE TO TOUCH COMMANDS, APPARENTLY THE CUSTOMER CONTINUE TO USE THE UNIT WHEN THE SCREEN BECAME UNRESPONSIVE TO TOUCH COMMANDS WHILE ON A PT. NO ISSUES NOTED. PT WAS PLACED ON A DIFFERENT UNIT, [NAME REMOVED] DID NOT HAVE SETTINGS." THE FOLLOWING INFO WAS DOCUMENTED BY A CARDINAL HEALTH FIELD SERVICE REP IN RESPONSE TO A CONVERSATION WITH A USER FACILITY REP DURING THE DEVICE EVAL. FIVE DAYS LATER: "[NAME REMOVED] (FS REP) - CUSTOMER REPORTED THAT UIM FROZE & UNIT STOPPED CYCLING WITH NO AUDIBLE ALARMS. NO PT INJURY REPORTED. CUSTOMER'S [IN HOUSE] SERVICE TICKET IS DATED 4-29-09. UNIT ERROR LOG SHOWS "CONFIG LOST" AND "SETTING LOST" ERRORS THIRTEEN DAYS PRIOR TO ORIGINAL DATE. ALL ALARMS ARE FUNCTIONING NORMALLY AT TIME OF FIELD SVC VISIT. REPLACE UIM DUE TO FREEZING, AND GDE DUE TO CONFIG ERROR". THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES FROM THE FDA ON 06/08/2009 AND THEN FORWARDED TO CARDINAL HEALTH, INC ON 06/08/2009. "EVENT DESC: PT WAS PLACED ON THE VENTILATOR. RESPIRATORY THERAPIST NOTICED THAT THERE WERE STATIC GRAPHS ON THE SCREEN AND NO EXHALED TIDAL VOLUMES. THE VENTILATOR WAS DISCONNECTED AND THE PT WAS MANUALLY VENTILATED BY AMBU BAG. PT WAS PLACED ON ANOTHER VENTILATOR." "DID THIS EVENT INVOLVE AND ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE: NO". "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 VIASYS 73CBK, VENTILATOR, CONTINOUS (RESPIRATOR) CBK CARDINAL HEALTH 207, INC. AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other