BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD

    MDR report key: 1894281 · Received November 4, 2010

    Report

    Report Number
    2021710-2010-00053
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K950484
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOCATION WHERE EVENT OCCURRED:(B)(4). THE FOREIGN IMPORTER (DISTRIBUTOR) DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO PROVIDED BY THE FOREIGN DISTRIBUTOR. (B)(4) ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE FOREIGN IMPORTER (DISTRIBUTOR) IN (B)(4) FOR THE RETURN OF THE ALLEGED FAULTY ALARM ASSEMBLY FOR EVAL. AS OF (B)(4) 2010, THE ALLEGED FAULTY ALARM ASSEMBLY HAS NOT BEEN RECEIVED. ONCE THE ALLEGED FAULTY ALARM ASSEMBLY IS RECEIVED AND THE EVAL IS COMPLETE, (B)(4) WILL SUBMIT A F/U MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY THE FOREIGN DISTRIBUTOR'S REP AND SENT TO (B)(4) TECH SUPPORT VIA E-MAIL. "IN [NAME OF FACILITY REMOVED], THEY EXPERIENCED AN INCIDENT THAT T-BIRD (SN (B)(4)) EMITTED ALARM MESSAGE ON THE DISPLAY, BUT THE ALARM ASSY DID NOT EMIT A SOUND ON (B)(4). WHEN WE INVESTIGATED THIS ALARM ASSY, WE FOUND THAT THE RESISTANCE BETWEEN BLACK AND RED LEAD WIRE WAS INFINITY. IT WOULD MEAN BREAKING OF WIRE IN THE ALARM ASSY. THIS INCIDENT IS SO IMPORTANT THAT WE WILL REPORT THIS ISSUE. PLEASE REFER THE ATTACHED PHOTO. THIS REPORT DOES NOT REQUIRE YOUR ANSWER. HOWEVER, IF NECESSARY, WE WILL SEND YOU THIS ALARM ASSY TO INVESTIGATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION T-BIRD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU ASKU