BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 2488217 · Received February 23, 2012

    Report

    Report Number
    2021710-2012-00007
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 23, 2012
    Report Date
    January 23, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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 PN: 01866. 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 ALSO FOUND THAT THE DEVICE WAS OUT OF CALIBRATION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THE DEVICE PASSED ALL TESTING TO INCLUDE ALARM FUNCTIONS PRIOR TO BEING SHIPPED TO THE END USER. THE USER FACILITY WAS SHIPPED A REPLACEMENT DEVICE. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS DID FIND (B)(4). 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 A CAREFUSION SALES REP. "SALES REP [NAME REMOVED] CALLED IN THIS BLENDER AS AN OUT OF BOX FAILURE. IT IS NOT PASSING INCOMING PERFORMANCE CHECKS, NOT ALARMING WHEN SET TO 30% AND O2 AND/OR AIR IS DISCONNECTED. GENERATED S/O AND RGA C-FOI238966."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ASKU