BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 2860291 · Received November 14, 2012

    Report

    Report Number
    2021710-2012-00106
    Event Type
    Other
    Date Received
    November 14, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K031745
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT TOOK PLACE IN (B)(6). NEITHER THE FOREIGN USER FACILITY NOR THE FOREIGN DISTRIBUTOR SUBMITTED A USER FACILITY/IMPORTER TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY THE DISTRIBUTOR. (B)(4). THE ALLEGED FAULTY DEVICE WAS RECEIVED BY CAREFUSION ON (B)(4) 2012, ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION CONCERNING THE EVENT WAS COPIED BY A CAREFUSION TECH SUPPORT SPECIALIST FORM AN E-MAIL FROM THE FOREIGN DISTRIBUTOR. "IT MADE A LEAD SOUND AGAIN AND THE CUSTOMER STOPPED USING IT. THE PT DEVELOPED BRADYCARDIA TEMPORARILY." THE FOLLOWING ADDITIONAL INFORMATION CONCERNING THE EVENT WAS COPIED FROM AN E-MAIL ATTACHMENT RECEIVED FROM THE FOREIGN DISTRIBUTOR ON (B)(4) 2012 THAT WAS IN RESPONSE TO AN E-MAIL SENT BY CARE FUSION SEEKING ADDITIONAL INFORMATION. "LEAK SOUND WAS HEARD. IT WAS NOT CLEAR WHETHER AUDIBLY ALARM WAS FUNCTIONED OR NOT AT THAT TIME. HOWEVER, WE THOUGHT THAT IT'S ALARM WAS FUNCTIONED. BECAUSE, THE UNIT'S AUDIBLY ALARM WAS ACTIVE WITH BOTH AIR AND OXYGEN GAS IN OUR SERVICE ROOM WHEN WE CHECKED IT LATER TIME. (B)(6) WAS SWITCHED OTHER M672P DRIVER AFTER IT'S EVENT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU Required Intervention ASKU