BEUDAMED
    FDA Adverse Event Injury Summary report: N

    560 USER INTERFACE

    MDR report key: 1971376 · Received January 7, 2011

    Report

    Report Number
    2184009-2011-00002
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 10, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWA
    PMA / PMN Number
    K070286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD: DEVICE HISTORY REVIEW IS PENDING. RESULTS: DEVICE HISTORY REVIEW AND INVESTIGATION COMPLETION IS PENDING. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: THE ERROR LOG FOR THIS UNIT WAS ANALYZED. IT APPEARED THE USER RESPONDED TO THE ERROR (BIOCONSOLE560.EXE) BY TAKING THE INSTRUMENT OFFLINE BY REDUCING THE RPM SPEED TO ZERO AND USING HAND CRANK UNTIL THE UNIT WAS SWITCHED TO A BACKUP UNIT. THE BASE UNIT COULD STILL HAVE INDICATED THAT THE MOTOR IS RUNNING. USER COULD POTENTIALLY HAVE CHOOSE TO OPERATE THE UNIT USING BASE UNIT, AS BASE IS BACKUP WHEN USER INTERFACE GOES DOWN. CONCLUSION: THE CAUSE FOR THIS EVENT CANNOT BE DETERMINED AT THIS TIME. ADDITIONAL INVESTIGATION IS PENDING. ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT DURING USE OF THIS BIOCONSOLE, AN ERROR MESSAGE WAS EXHIBITED INDICATING "APPLICATION BIOCONSOLE560.EXE HAS PERFORMED AN ILLEGAL OPERATION AND WILL BE SHUT DOWN. IF THE PROBLEM PERSISTS, CONTACT THE PROGRAM VENDOR. (B)(6). THE UNIT OPERATOR SWITCHED TO HANDCRANK UNTIL A BACKUP UNIT COULD BE BROUGHT IN. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 560 USER INTERFACE DWA MEDTRONIC PERFUSION SYSTEMS 560UI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R