BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPULSE 7000DP

    MDR report key: 3035891 · Received February 26, 2013

    Report

    Report Number
    2921581-2013-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 19, 2013
    Manufacturer
    FLUKE BIOMEDICAL
    Product Code
    DRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BACKGROUND: CUSTOMER CLAIMED AN IMPULSE 7000 UNIT SN (B)(4) IS SUSPECT TO INTERMITTENT FAILURES IN WHICH DEFIBRILLATOR ENERGY READINGS ARE OUT OF THE EXPECTED RANGE NOTED IN THE SPECIFICATIONS BY FLUKE BIOMEDICAL. THE EXPECTED RANGE WAS DETERMINED AS ENERGY READING +/- (1 PERCENT (ENERGY READING) + 0.1) J BY FLUKE BIOMEDICAL. THIS UNIT WAS RECEIVED WITH 2.06 FIRMWARE VERSION WHILE THE MOST UPDATED FIRMWARE VERSION IS 2.07. INVESTIGATION PLAN: AFTER REVIEWING CUSTOMER CLAIMS, A SET OF TESTS IS DESIGNED TO ACCESS THE ENERGY OUTPUT READING OF THE SUSPECT UNIT AND TO COMPARE THE RESULTS WITH THE FLUKE BIOMEDICAL SPECIFICATIONS. AS PART OF THE STANDARD TEST SETUP IN SERVICE, WE WILL MEASURE THE ENERGY OUTPUT OF THE DEFIBRILLATOR AND THE SUSPECT UNIT SIMULTANEOUSLY. WE WILL USE A LIFEPAK DEFIBRILLATOR TO PROVIDE DIFFERENT ENERGY OUTPUTS TO THE IMPULSE 7000 UNITS. FOLLOWING TESTS WILL BE PERFORMED IN ORDER TO REPRODUCE INTERMITTENT FAILURES AND INVESTIGATE THE CAUSES: THE UNIT WILL BE TESTED WITH "AS FOUND" (B)(4), I.E., VERSION 2.06 AT FIVE DIFFERENT ENERGY LEVELS (10J, 50J, 100J, 250J, AND 360J). THIS TEST IS TO EXAMINE THE UNIT IN A WIDE RANGE OF ENERGY LEVELS AND EXPOSE ANY POSSIBLE INTERMITTENT FAILURES.; THE FIRMWARE OF THE SUSPECT UNIT WILL BE UPGRADED TO VERSION 2.07 AND THE UNIT WILL BE TESTED AT FIVE ENERGY LEVELS MENTIONED ABOVE. THIS TEST IS PERFORMED TO ENSURE THAT THE UNIT PERFORMS ACCORDING TO THE SPECIFICATIONS WITH THE MOST UPDATED FIRMWARE VERSION. INVESTIGATION FINDINGS: NO FAILURE WAS OBSERVED AND ALL READINGS WERE IN ACCORDANCE WITH THE SPECIFICATIONS. NO FAILURE WAS OBSERVED AND ALL READINGS WERE IN ACCORDANCE WITH THE SPECIFICATIONS. ALL DATA ARE DOCUMENTED IN (B)(4). CONCLUSIONS: THE UNIT PASSED ALL TESTS AND NO INTERMITTENT FAILURE IN THE DEFIBRILLATOR ENERGY READING WAS FOUND. SINCE NO FAILURE WAS OBSERVED BY TWO INDEPENDENT ENGINEERS, NO FURTHER ACTION IS REQUIRED AND THE STATUS IS "COULD NOT REPRODUCE FAILURE, NO PROBLEM FOUND". WE SUGGEST THAT CUSTOMER KEEP THE UNIT FIRMWARE UP-TO-DATE. FOLLOW-UP ACTIVITIES. AT THE CONCLUSION OF OUR INVESTIGATION, THE FINAL REPORT WILL BE UPLOADED TO THE MASTER CONTROL.

    Description of Event or Problem · 1

    INTERMITTENT OUT OF TOLERANCE DEFIB PULSE PULSE MEASUREMENTS. E-MAIL RECEIVED FROM (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83137 IMPULSE 7000DP IMPULSE 7000DP DRL FLUKE BIOMEDICAL 7000DP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA