BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 1933433 · Received December 3, 2010

    Report

    Report Number
    2021710-2010-00060
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K020746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION SERVICE DEPT TECH. THE CAREFUSION SERVICE DEPT TECH EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE FAILURE WAS THAT THE CABLE CONNECTOR FOR THE ALARM LOUDNESS POTENTIOMETER WAS NOT FULLY SEATED INTO THE RECEPTACLE J900 ON THE MAIN PCBA. THE CAREFUSION SERVICE DEPT TECH RE-SEATED THE CABLE CONNECTOR INTO THE RECEPTACLE J900 ON THE MAIN PCBA AND RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION THE DEVICE WAS RETURNED TO (B)(6) READY TO BE PLACED BACK INTO SERVICE. CAREFUSION CONDUCTED A REVIEW OF OUR COMPLAINT SYSTEM FOR THE PAST 90 DAYS AND NO LIKE FAILURES WERE FOUND THUS NO TREND HAS BEEN IDENTIFIED AND CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A (B)(6) REPRESENTATIVE. "THE CUSTOMER HAS JUST REC'D THE UNIT FROM (B)(4), AND ON CHECK OFF BIOMED NOTED SOUND/VOLUME WHEN AN ALARM IS TRIGGERED WAS NOT FUNCTIONAL. BIOMED WAS CYCLING THE UNIT ON DEFAULT SETTINGS. BIOMED CHECKED THE VOLUME POT TURNED ACCORDINGLY, I SUGGESTED HE OPEN THE UNIT AND CHECK THE CONNECTION. I WILL PROCESS THE UNIT IN FOR SERVICE AGAIN. BIOMED WILL CALL IN CASE HE CANCELS RMA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VENTILATOR, CONTINUOUS , FACILITY USE/CBK CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA