BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 1034014 · Received April 24, 2008

    Report

    Report Number
    2021710-2008-00042
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 22, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH SERVICE DEPT TECH. THE CARDINAL HEALTH SERVICE DEPT TECH EVALUATED THE DEVICE AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS THAT THE DEVICE WAS OUT OF CALIBRATION. UNRELATED TO THE REPORTED EVENT THE SERVICE DEPT TECH FOUND THAT THE DEVICE WAS MISSING THE SPRING FROM THE ALARM CAP ASSEMBLY AND WAS MISSING THE KNOB CAP FROM THE O2% CONTROL KNOB. THE CARDINAL HEALTH SERVICE DEPT TECH REPLACED THE AFFECTED COMPONENTS AND RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE CUSTOMER READY TO BE PLACED BACK INTO SERVICE. NO COMPONENT OR SYSTEM TREND HAS BEEN IDENTIFIED AND THIS IS CONSIDERED TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "THE CUSTOMER IS SENDING THE UNIT IN FOR REPAIR SECONDARY TO AT FIO2 GREATER THAN 60% IT DOES NOT DELIVER PER SPEC THE UNIT DELIVERS 5% MORE THAN WHAT IT IS SET FOR ISSUE WAS IDENTIFIED THROUGH BIO-MED THROUGH THEIR VERIFICATION OF FIO2 ACCURACY VIA KNOWN GOOD EXTERNAL ANALYZER. NO PT ISSUES NOTED, I WILL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD AIR/O2 BLENDER BZR CARDINAL HEALTH 207, INC BLENDER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA