BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 2505165 · Received March 21, 2012

    Report

    Report Number
    2021710-2012-00018
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT DERIVED BASED ON INFORMATION DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH THE DISTRIBUTOR'S 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. 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. THE DISTRIBUTOR WAS SHIPPED A REPLACEMENT DEVICE. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS DID FIND TWO VERIFIED LIKE FAILURES. HOWEVER, AS THESE ARE KNOWN FAILURES CAUSED OR CONTRIBUTED TO BE 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 THE DISTRIBUTOR'S REPRESENTATIVE. "(B)(4) WARRANTY REPAIR AUDIBLE ALARM DOES NOT WORK."

    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