BEUDAMED
    FDA Adverse Event Injury Summary report: N

    560 USER INTERFACE

    MDR report key: 1698313 · Received May 19, 2010

    Report

    Report Number
    2184009-2010-00009
    Event Type
    Injury
    Date Received
    May 19, 2010
    Date of Event
    April 20, 2010
    Report Date
    April 20, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWA
    PMA / PMN Number
    K070286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ANALYSIS: SERVICE WAS PERFORMED ON THE DEVICE. THE TECH WAS NOT ABLE TO DUPLICATE THE DISPLAY BLANKING OUT; HOWEVER, THE BATTERIES WERE NOTED TO BE VERY LOW AND THEY WOULD NOT CHANGE. THE BATTERIES WERE CHANGED OUT AND CHARGED, THE UNIT WAS THEN OUT THROUGH PERFORMANCE TESTING, CALIBRATED TO SPECIFICATION AND RETURNED BACK TO THE CUSTOMER. CONCLUSION: BASED ON ANALYSIS, THE CLINICAL OBSERVATION WAS CONFIRMED. THE LIKELY CAUSE OF THE DISPLAY ISSUES OBSERVED WAS DUE TO THE LOW BATTERY CONDITION OF THE UNIT. ACCORDING TO THE CUSTOMER, THEY OBSERVED EITHER A LOW BATTERY ALARM OR AC POWER ALARM, BOTH INDICATE AN ATTEMPT OF THE UNIT TO RUN ON BATTERY POWER AND THE UNIT WAS FOUND TO HAVE A LOW BATTERY. IF THE BATTERY CHARGE IS LOW, RECHARGING TO 90% CAPACITY TAKES APPROX 18 HOURS AND A FULL CHARGE REQUIRES APPROX 24 HOURS AS STATED ON PAGE 4-9, REV., 1.0 OF THIS PRODUCT'S INSTRUCTIONS FOR USE. IF THE UNIT IS PLUGGED INTO AN AC POWER SOURCE, THE UNIT WOULD FUNCTION AND THE BATTERIES WOULD CHARGE DURING USE; HOWEVER, IF THE BATTERIES WERE TOO LOW AND THE UNIT LOST AC POWER, THE UNIT MAY SHUT DOWN IF THE BATTERIES WERE TOO LOW. THE UNIT WAS MANUFACTURED 12/22/2005 (B) (4) AND THE BATTERY LIFE EXPECTATION OF 3-5 YRS HAD BEEN MET.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFO THAT THIS BIO-CONSOLE DISPLAY BLANKED OUT DURING A PROCEDURE AND THE MOTOR WOULD NOT SPIN. THE HAND CRANK WAS REQUIRED UNTIL THE UNIT COULD BE CHANGED OUT. THE CUSTOMER REPORTED THAT THEY DID SEE EITHER A LOW BATTERY OR LOSS OF AC POWER ALARM. THERE WERE NO ADVERSE PT EFFECTS.

    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 Required Intervention