BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 1639468 · Received March 17, 2010

    Report

    Report Number
    2021710-2010-00010
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 17, 2010
    Manufacturer
    CARFUSION
    Product Code
    BZD
    PMA / PMN Number
    K051226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION SERVICE DEPT TECH. THE CAREFUSION SERVICE DEPT TECH EVALUATED THE DEVICE AND WAS ABLE TO REPRODUCE THE REPORT OF "NO AUDIBLE ALARMS". THE CAREFUSION SERVICE DEPT TECH DETERMINED THAT THE ROOT CAUSE OF THAT ISSUE WAS A DEFECTIVE ALARM ON THE MAIN BOARD. THE MAIN BOARD WAS REPLACED BY THE SERVICE DEPT TECH PRIOR TO PERFORMING A PM AND RUNNING THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE UNIT WAS RETURNED TO THE CUSTOMER READY TO BE PLACED BACK INTO SERVICE. A FOLLOW UP MDR REPORT WILL BE SENT SHOULD FURTHER INFO BECOME AVAILABLE.

    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 TO REPORT THAT DURING SET UP, THE END-USERS NOTICED THAT THERE WAS NO AUDIBLE ALARMS. THE VISUAL ALARM ALERTED THE ALARM CONDITION, BUT THERE WAS NO AUDIBLE ALERT. (NO PT INVOLVEMENT). HE WOULD LIKE TO SEND THIS DRIVER (B)(4) FOR REPAIR AND ANNUAL PM. THE LAST TIME HE DID A PM ON AN AIRLIFE DRIVER, HE FOUND IT VERY COMPLICATED. I WILL HAVE THIS DRIVER RETURNED (B)(4). HE REQUESTS TO BE CALLED WITH AN ESTIMATE. I PROVIDED SERVICE RATES AND PM KIT PRICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH 73 - BZD VENTILATOR, NON-CONTINUOUS BZD CARFUSION AIRLIFE NCPAP DRIVER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA