BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 4203655 · Received July 22, 2014

    Report

    Report Number
    2021710-2014-00042
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K051226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN. THE CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE FAILURE WAS FAULTY BUZZER ASSEMBLY ON THE MAIN PCBA. THE CAREFUSION FACTORY SERVICE DEPARTMENT REPLACED 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 THE CUSTOMER READY TO BE PLACED BACK INTO SERVICE. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST TWO YEARS REVEALED NO TRENDS INVOLVING THE SAME PART NUMBERS AND/OR FAILURE MODES, THUS AT PRESENT CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT. IN ADDITION THE AIRFLIFE NCPAP DRIVER HAS BEEN DISCONTINUED AND AS OF (B)(4) 2010 THE AIRLIFE DRIVER IS NO LONGER MANUFACTURED OR SOLD.

    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 USER FACILITY REPRESENTATIVE(S). "[NAME REMOVED] CALLED REQUESTING A RMA TO SEND THIS UNIT IN FOR REPAIR. THE RTS NOTICED THIS ISSUE DURING SET UP. (HE UNDERSTANDS ABOUT THE LIMITED SUPPORT FOR THE AIRLIFE DRIVER) HE EXPLAINS THAT THE ISSUE IS WITH THE ALARM. WHEN TURNED ON, THE UNIT ALARMS APPROPRIATELY (VISUAL AND AUDIBLY), BUT AFTER A FEW MINUTES, THE AUDIBLE DISAPPEARS. ONLY THE VISUAL ALARM REMAINS. HE CAN TURN THE UNIT OFF AND THEN BACK ON AGAIN AND THE AUDIBLE ALARM COMES BACK ON. AFTER A FEW MINUTES OF SOUNDING, THE AUDIBLE GOES OUT AGAIN. HE WOULD LIKE THIS EVALUATED AND REPAIRED IF POSSIBLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429031 CARDINAL HEALTH AIRLIFE NCPAP DRIVER /BZD BZD CAREFUSION AIRLIFE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA