BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 1337259 · Received February 11, 2009

    Report

    Report Number
    2021710-2009-00004
    Event Type
    Malfunction
    Date Received
    February 11, 2009
    Date of Event
    October 16, 2008
    Report Date
    February 11, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY CAL-MED DIVERSIFIED (THIRD PARTY SERVICE CO) FIELD SERVICE REP. THE CAL-MED DIVERSIFIED FIELD SERVICE REP REVIEWED THE DEVICE ERROR CODE LOG AND WAS ABLE TO VERIFY THAT THE REPORTED EVENT DID OCCUR IN 2008. HOWEVER, AFTER EVALUATING THE DEVICE HE WAS UNABLE TO REPRODUCE THE REPORTED FAILURE. THUS NO ROOT CAUSE WAS DETERMINED. HE THEN RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION THE UNIT WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE. NO COMPONENT AND SYMPTOM TREND HAS BEEN IDENTIFED AND THIS EVENT IS CONSIDERED TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A MAUDE EVENT REPORT RECEIVED BY CARDINAL HEALTH FROM THE FDA ON 1/16/2009. "PT WAS IN ICU BEING MONITORED. PT SAT NOTED AT 80%, BUT NO CHANGE IN OTHER V/S. RT AND RN AT BEDSIDE WHEN VENT NOTED TO HAVE "X DTR FAULT" ON SCREEN. VENT WAS TAKEN OFF-LINE STAT AND REPLACED. PT WAS BAGGED DURING SWAP AND SAT RETURNED TO > 90%. 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. "CUSTOMER UNIT IS ALARMING TRANSDUCER FAULT, CUSTOMER WANTS FIELD SERVICE TO COME OUT AND CORRECT THIS PROBLEM." THE FOLLOWING ADDITIONAL INFO CONCERNING THE EVENT AND THE EVAL OF THE DEVICE WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH CAL-MED DIVERSIFIED (THIRD PARTY SERVICE CO) REP. "UNIT WAS ON PT WHEN XDCR FAULT OCCURRED. UNIT CONTINUED TO CYCLE O.K., BUT PT WAS SWITCHED TO ANOTHER VELA. NO PT INJURY REPORTED. INSPECTED AND TESTED UNIT - UNIT PERFORMED TO FACTORY SPECS, XDCR FAULT COULD NOT BE REPRODUCED." THE FOLLOWING ADDITIONAL INFO CONCERNING THE EVENT WAS COPIED FROM A LETTER RECEIVED FORM THE USER FACILITY ON 12/5/2008 THAT WAS IN RESPONSE TO A LETTER SENT BY CARDINAL HEALTH SEEKING ADDITIONAL INFO. "2008 - 6 PM RT CALLED, FOR PT'S STAS DROPPING TO 60%. PT SUCTIONED, PT WAS A NO CODE AND EXPECTED TO BE EXPIRED. RT SAW XDCR CODE AND SWITCH VENT OUT, PT THEN RECOVERED IMMEDIATELY. THE UNIT DID AUDIBLY ALARM." "PT RETURNED TO PREVIOUS STATE ON NEW VENTILATOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS CBK VOLUME VENTILATOR CBK CARDINAL HEALTH 207, INC. VELA *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR