BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 2505442 · Received March 23, 2012

    Report

    Report Number
    2021710-2012-00020
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K031745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN DISTRIBUTOR DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT WAS DERIVED BASED ON INFO PROVIDED BY THE FOREIGN DISTRIBUTOR. (B)(4). THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FAILURE ANALYSIS LAB TECH AND THE CAREFUSION FACTORY SERVICE REP. THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY BUZZER ON THE MAIN PROCESSOR PCBA. UNRELATED TO THE REPORTED EVENT THE CAREFUSION FACTORY SERVICE REP DETERMINED THAT THE DEVICE WAS OVERDUE FOR A 2 YEAR PREVENTATIVE MAINTENANCE (PM) SERVICE. THE FOREIGN DISTRIBUTOR INFORMED CAREFUSION THAT THEY WILL PERFORM THE 2 YEAR PREVENTATIVE MAINTENANCE (PM) SERVICE ON THE DEVICE ONCE THEY RECEIVE THE DEVICE BACK FROM CAREFUSION. THE CAREFUSION FACTORY SERVICE REP REPLACED THE MAIN PROCESSOR PCBA, UPDATED THE DEVICE'S SOFTWARE TO THE LATEST REVISION, AND PERFORMED A COMPLETE CALIBRATION AND CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION THE DEVICE WAS RETURNED TO THE FOREIGN DISTRIBUTOR. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS RESULTED IN ZERO LIKE FAILURES, THUS CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFO CONCERNING THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO AN E-MAIL FROM THE FOREIGN DISTRIBUTOR. "[NAME REMOVED] EMAILED REPORTING AN ISSUE FOUND WITH A SIPAP (B)(4) THAT WAS INSTALLED IN (B)(6) 2008. COMPLAINT: THE BUZZER STOPPED WORKING. THE OPERATION INDICATOR AND ALARMS ARE WORKING, BUT THEY ARE ONLY VISUAL; THERE IS NO AUDIBLE ALARM/SOUND. THEY EVALUATED AND SUSPECT A MALFUNCTION OF THE BUZZER. SINCE THE BUZZER IS ON THE MAIN PROCESSOR BOARD (B)(4) (NOT SELLABLE), THEY WANT AN ESTIMATE OF WHAT IT WOULD COST TO SEND IT IN FOR THIS REPAIR."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA