BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 1106660 · Received August 7, 2008

    Report

    Report Number
    2021710-2008-00064
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 7, 2008
    Report Date
    August 6, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO PHONE CONVERSATIONS WITH A USER FACILITY REPRESENTATIVE. PATIENT CIRCUIT SUPPORT ARM DRIFTS DOWN - THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH FIELD SERVICE REP. THE CARDINAL HEALTH FIELD SERVICE REP. EVALUATED THE DEVICE'S PATIENT CIRCUIT SUPPORT ARM AND FOUND THAT THE JOINTS WERE NOT TIGHTENED SUFFICIENTLY TO ENSURE THAT THE PATIENT CIRCUIT SUPPORT ARM WOULD NOT DROOP. THE CARDINAL HEALTH FIELD SERVICE REP. TIGHTENED THE JOINTS ON THE PATIENT CIRCUIT SUPPORT ARM SO THAT IT NO LONGER DROPPED. CARDINAL HEALTH HAS INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST (CAR) TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO PHONE CONVERSATIONS WITH A USER FACILITY REPRESENTATIVE. [2008] "[NAME REMOVED] CALLED AND REPORTED THAT FIVE OF THE PT CIRCUIT SUPPORT ARMS ARE DROPPING AND WILL NOT TIGHTEN ENOUGH TO HOLD THE CIRCUITS IN PLACE. THEY CLAIM THAT THESE PT SUPPORT ARMS, WHEN THEY DROPPED THEY PULLED THE TRACHEA TUBES OUT OF THE PT. THERE WAS NO HARM OR PROBLEMS WITH THE PT'S AS THE STAFF WAS CLOSE BY. NO OTHER DETAILS WERE AVAILABLE. THEY WANT FIELD SERVICE IN TO TIGHTEN THEM AS THEY WERE NOT WILLING TO TRY TO TIGHTEN THEM AND THEY CLAIM ALL ARE UNDER WARRANTY." [TW DAYS LATER] "CALLED AND LEFT [NAME REMOVE] A MESSAGE DETAILING THAT WE NEED TO HAVE THEM REPORT THE OTHER FOUR VENTS THAT HAVE HAD THIS ISSUE WITH SUPPORT ARMS. AWAITING A RETURN CALL." [TWO DAYS LATER] "CUSTOMER ([NAMED REMOVED]) CALLED BACK TO INFORM US THAT NO PATIENT INCIDENT OCCURRED AS A RESULT OF THIS ISSUE- THE PREVIOUS COMPLAINT OF ET TUBE BEING PULLED WAS FALSE- A MISCOMMUNICATION ONLY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1