BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 1172345 · Received September 19, 2008

    Report

    Report Number
    2021710-2008-00084
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 18, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURE. EVENT CODES WERE DERIVED BASED ON THE INFORMATION DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH. THE CARDINAL HEATH FAILURE ANALYSIS LAB TECH EVALUATED THE AIR/O2 BLENDER AND WAS UNABLE TO REPRODUCE THE REPORTED FIO2 OUT OF RANGE FAILURE. THUS NO ROOT CAUSE WAS DETERMINED. THE AIR/O2 BLENDER WILL BE SENT TO THE MANUFACTURING DEPARTMENT TO BE REWORK TO NEW. A REPLACEMENT AIR/O2 BLENDER WAS SENT TO THE USER FACILITY.

    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 REPRESENTATIVE. "CUSTOMER CALLED IN STATING THAT THE BLENDER THEY HAD PURCHASED BACK IN MARCH IS DEFECTIVE. CUSTOMER STATES THAT THEY RECENTLY HAD TAKEN THEY BLENDER OUT OF BOX AND ATTEMPTED TO DO A PERFORMANCE CHECK AND NOTICE THAT THE BLENDER WOULD NOT PASS PERFORMANCE CHECK. CUSTOMER STATED THAT THE FIO2 PERCENTAGES WERE OUT OF SPEC, AND BLENDER WAS NOT FUNCTIONING APPROPRIATELY. I WILL SENT REPLACEMENT BLENDER UNDER WARRANTY, AND ISSUE A RGA FOR DEFECTIVE BLENDER TO COME BACK TO THE FACTORY FOR FA LAB ANALYSIS".

    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