BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER

    MDR report key: 9716948 · Received February 17, 2020

    Report

    Report Number
    2184149-2020-00023
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    January 22, 2020
    Report Date
    March 13, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05414734210713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER WAS RECEIVED FOR EVALUATION. THE AMPLIFIER WAS POWERED ON AND PASSED THE POWER ON SELF-TEST (POST). UPON ESTABLISHING COMMUNICATION TEST STATION, IT WAS OBSERVED THE SERIAL NUMBER DISPLAYED WAS ¿JCA¿. REVIEW OF THE ERROR LOGS IDENTIFIED DEFICIENCY TOWARDS THE CATH AMP BOARD ON SLOT 8. THE CATH AMP BOARD CONSISTENTLY EXPERIENCED SHUTDOWN AND COMMAND TIMEOUTS. THE ROOT CAUSE WAS ISOLATED TO THE CATH AMP BOARD ON SLOT 8. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. FURTHER INFORMATION REGARDING THE EVENT WERE REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE AMPLIFIER WOULD NOT BOOT. THE PATIENT WAS ON THE TABLE AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS STABLE AND THE PROCEDURE WAS RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181325 ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. 100015555 5371177 05414734210713

    Patients

    Seq Age Sex Outcome Treatment
    1 Other