BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 1009575 · Received February 6, 2008

    Report

    Report Number
    2021710-2008-00004
    Event Type
    Malfunction
    Date Received
    February 6, 2008
    Date of Event
    December 6, 2007
    Report Date
    February 6, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 FOLLOWING WERE CONTRIBUTING FACTURES IN THE ROOT CAUSE OF THE REPORTED EVENT; A DEFECTIVE DUCK BILL CHECK VALVE WAS RESTRICTING GAS FLOW INTO THE DEVICE AND THE CONTROL KNOB WAS LOOSE ON THE CONTROL SHAFT THUS, WHEN THE KNOB WAS TURNED THE SHAFT DID NOT TURN. THE CARDINAL HEALTH SERVICE DEPT TECH REPLACED THE EFFECTED COMPONENT, TIGHTENED THE CONTROL KNOB ONTO THE CONTROL SHAFT AND RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND TESTING TO ENSURE THAT THE DEVICE MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE USER FACILITY READY TO BE PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A LETTER FROM THE DISTRIBUTOR IN ANOTHER COUNTRY. "FACILITY HAS REC'D A PRODUCT COMPLAINT FOR THE 11322 BLENDER. AS YOU ARE THE IDENTIFIED MFR OF THE MEDICAL DEVICE, WE ARE FORWARDING THE COMPLAINT INFO ORIGINALLY SENT TO US FROM THE CUSTOMER TO YOU FOR INVESTIGATION AND VIGILANCE REPORTING. THE CUSTOMER HAS REQUESTED A RESPONSE. COMPLAINT INFORMATION: EVENT DATE: 2007. MODEL 11322. UNIT DOES NOT DELIVER OXYGEN AND DOESN'T ALARM. NURSE WAS TRYING TO RESUSCITATE, BABY WASN'T RESPONDING. CHANGED TO 100% OXYGEN (WITHOUT BLENDER), NO HARM SUSTAINED. REP IS REQUESTING FORMAL SERVICE REPORT OF SPECIFIC DETAILS AS TO CONFIRMATION OF IDENTIFIED PERFORMANCE ERROR, AND CORRECTIVE ACTION(S) ENTAILED. THIS DETAIL IS IMPORTANT TO HOSP INTERNAL DOCUMENTATION RELATED TO THIS PT CARE INCIDENT." THE FOLLOWING ADDITIONAL INFO CONCERNING THE EVENT WAS COPIED FROM A LETTER FROM THE USER FAICLITY THAT WAS IN RESPONSE TO A LETTER SENT BY CARDINAL HEALTH SEEKING ADDITIONAL INFO AND FROM THE USER FACILITY MEDWATCH REPORT. "MICROBLENDER DID NOT AUDIBLY ALARM. MICROBLENDER DELIVERED 21% O2 ON ALL SETTINGS." "THERE WAS A REPORTED PROBLEM WITH ONE OF THE TWO OUTLETS THAT DID NOT DELIVERY OXYGEN. NO PT HARM." "BIOMEDICAL ASSESSMENT: TESTING DID NOT DEMONSTRATE PROBLEM. THE OXYGEN DEVICE [SPLITTER] WAS DISASSEMBLED AND INSPECTED. THE INSIDE PASSAGES WERE CLEAR AND CLEAN AND THE CHECK VALVES FUNCTIONED PROPERLY. THE DEVICE [SPLITTER] WAS REASSEMBLED AND TESTED WITH THE SAME RESULTS. THE BIOMED TECH RETURNED TO SPLITTER TO THE UNIT AND ASKED THE STAFF TO RECREATE THE PROBLEM THAT LED THE TECH TO FINDING A DEFECTIVE BIRD OXYGEN BLENDER. THE BLENDER DOES NOT PASS THROUGH ANY OXYGEN, ONLY AIR AND THE ALARM DOES NOT WORK. THE DEVICE WAS SEQUESTERED AN WILL BE SENT TO THE MFR FOR EVAL AND REPAIR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD AIR/02 BLENDER BZR CARDINAL HEALTH 207, INC BLENDER *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN DUAL| MEDICAL OXYGEN OUTLET