BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 2072578 · Received April 21, 2011

    Report

    Report Number
    2021710-2011-00030
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BZR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION FAILURE ANALYSIS LAB TECH AND THE CAREFUSION FACTORY SERVICE REP. THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE FAILURE WAS A DAMAGED ALARM REED PLATE. THE CAREFUSION FAILURE ANALYSIS LAB TECH WAS UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE TO THE ALARM REED PLATE. HOWEVER, THIS TYPE OF DAMAGE IS GENERALLY CAUSED BY THE APPLICATION OF A MECHANICAL FORCE OR PRESSURE AGAINST THE REED ON THE ALARM REED PLATE. UNRELATED TO THE REPORTED EVENT THE CAREFUSION FAILURE ANALYSIS, LAB TECH FOUND THE FOLLOWING ADDITIONAL ISSUE: THE AUXILIARY BLEED FLOW READS OUT OF RANGE (E.G. HIGH) DUE TO A FAULTY AUXILIARY BLEED FITTING. THE CAREFUSION FACTORY SERVICE REP REPLACED THE ALARM REED PLATE, AUXILIARY BLEED FITTING AND RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE USER FACILITY READY TO BE PLACED BACK INTO SERVICE. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS DID FIND ONE VERIFIED LIKE FAILURE. HOWEVER, AS THESE ARE KNOWN FAILURES CAUSED OR CONTRIBUTED TO BY AN UNAPPROVED MEANS OF FORCE OR PRESSURE, ANOTHER INVESTIGATION IS NOT REQUIRED.

    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 USER FACILITY REPRESENTATIVE: "BLENDER JUST RECEIVED BACK FROM FACTORY OVERHAUL ON CALL (B)(4). HE SAID HE TESTED IT AND HE CAN SLOWLY DROP THE INLET PRESSURE DOWN TO ZERO ON THE O2 SIDE AND IT WILL NOT ALARM. HE DID HAVE KNOB AT 60% SETTING WHEN TESTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD MIXER, BREATHING GASES, ANESTHESIA INHALATION / BZR BZR CAREFUSION MICROBLENDER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA