BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 2504262 · Received February 29, 2012

    Report

    Report Number
    2021710-2012-00010
    Event Type
    Malfunction
    Date Received
    February 29, 2012
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN DISTRIBUTOR DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. (B)(4). CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE CAREFUSION (B)(4) SERVICE CENTER FOR THE RETURN OF THE ALLEGED FAULTY ALARM ASSEMBLY FOR EVALUATION. AS OF (B)(4) 2012, THE ALLEGED FAULTY ALARM ASSEMBLY HAS NOT BEEN RECEIVED. ONCE THE ALLEGED FAULTY ALARM ASSEMBLY IS RECEIVED AND THE EVALUATION IS COMPLETE, CAREFUSION WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING INFO CONCERNING THE EVENT WAS DOCUMENTED BY CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A CAREFUSION (B)(4) REP. "[NAME REMOVED], STATES THEY HAVE 2 NEW BLENDERS SN (B)(4), THAT THE REED ALARM IS NOT GIVING AN AUDIBLE SOUND WHEN TESTING AND IT GOES INTO ALARM BYPASS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA