BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPULSE 7000DP

    MDR report key: 3035892 · Received February 26, 2013

    Report

    Report Number
    2921581-2013-00002
    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 SPECIFIED RANGE NOTED IN THE SPECIFICATIONS BY FLUKE BIOMEDICAL. THE EXPECTED ACCURACY RANGE WAS DETERMINED AS (B)(4) BY FLUKE BIOMEDICAL. THIS UNIT WAS RECEIVED WITH 2.02 FIRMWARE VERSION WHILE THE MOST UPDATED FIRMWARE VERSION IS 2.07. INVESTIGATION PLAN: AFTER REVIEWING CUSTOMER CLAIMS, A SET OF TESTS IS DESIGNED TO ASSESS 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, (B)(4). FOLLOWING TESTS WILL BE PERFORMED IN ORDER TO REPRODUCE INTERMITTENT FAILURES AND INVESTIGATE THE CAUSES. THE SUSPECT UNIT WITH "AS FOUND" FIRMWARE 2.02 AND REFERENCE UNIT WILL BE TESTED AT DIFFERENT ENERGY LEVELS ((B)(4)). THIS TEST WILL BE PERFORMED TO EXAMINE THE SUSPECT UNIT IN A WIDE RANGE OF ENERGY LEVELS AND OBSERVE ANY FAILURE TENDENCY AT EACH LEVEL. A KNOWN WORKING UNIT WITH "AS FOUND" FIRMWARE WILL BE TESTED IN THE STANDARD REST SETUP IN SERVICE. THIS UNIT WILL BE TESTED AGAIN AFTER THE FIRMWARE IS REPLACED TO VERSION 2.02, WHICH WAS THE FIRMWARE FOUND ON THE CUSTOMER UNIT INITIALLY. THIS TEST IS DESIGNED TO DETERMINE IF THE FIRMWARE ITSELF IS THE CAUSE OF THE FAI... INTERMITTENT FAILURES WERE OBSERVED WITH THE CUSTOMER UNIT WHEN TESTED WITH FIRMWARE 2.07 INSTALLED. FAILURE MODE WAS NOT DEPENDENT ON FIRMWARE VERSION. WHEN FAILURES WERE OBSERVED, THE POST ATTENUATOR RESISTANCE WAS LARGER THAN THE CASES WHEN THE UNIT READINGS WERE IN SPECIFIED RANGE. THIS VARIANCE POINTS TO SUSPECT RELAY IN 'AS FOUND' HARDWARE. SIMPLE CONTACT RESISTANCE TEST SHOWED THAT RELAY WAS DAMAGED. THE RELAY WAS REPLACED AND (B)(4) TESTS AT (B)(4) ENERGY LEVELS ((B)(4)) WERE PERFORMED TO ENSURE THAT FAILURE MODE COULD NOT BE REPRODUCED AND THE POST-ATTENUATOR RESISTANCE REMAINS STEADY. AFTER COMPLETING THIS TEST, BOTH CONDITIONS WERE CONFIRMED. (B)(4). CONCLUSIONS: AFTER COMPLETING OUR INVESTIGATION INTO THE INTERMITTENT, OUT OF SPECIFICATION ISSUE REPORTED ON THE IMPULSE 7000, SN (B)(4)5, IT WAS CONCLUDED THE ROOT CAUSE OF THE ISSUE WAS A BAD RELAY ON THE POST-ATTENUATOR CIRCUIT.

    Description of Event or Problem · 1

    INTERMITTENT OUT OF TOLERANCE DEFIB PULSE, PULSE MEASUREMENTS. E-MAIL RECEIVED FROM (B)(6) DATED (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83144 IMPULSE 7000DP IMPULSE 7000DP DRL FLUKE BIOMEDICAL 70000DP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA