BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 1172178 · Received September 18, 2008

    Report

    Report Number
    2021710-2008-00083
    Event Type
    Malfunction
    Date Received
    September 18, 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
    BIOMEDICAL ENGINEER

    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 FAILURE ANALYSIS LAB TECH. THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH EVALUATED THE AIR/O2 BLENDER AND WAS UNABLE TO REPRODUCE THE REPORTED EVENT. THUS NO ROOR CAUSE WAS DETERMINED. THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH DID FIND DURING THE EVAL THAT THE O2 ALARM WAS OUT OF CALIBRATION BECAUSE IT DID NOT FUNCTION BETWEEN 28-32 PSI AS REQUIRED BY THE LOWFLOW O2 MICROBLENDER OPERATIONAL VERIFICATION CHECK SHEET TEST SECTION 7.3.4. THE AIR/O2 BLENDER WILL BE SENT TO THE MFG DEPARTMENT FOR O2 ALARM RECALIBRATION AND 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 REP. "CUSTOMER CALLED IN STATING THAT THE BLENDER THEY HAD PURCHASED BACK IN MARCH IS DEFECTIVE. CUSTOMER STATES THAT THEY RECENTLY HAD TAKEN THE 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 SEND REPLACEMENT BLENDER UNDER WARRANTY AND ISSUE A RGA FOR DEFFECTIVE 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