BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIEWMATE Z ULTRASOUND CONSOLE WBATTERY ZS3

    MDR report key: 10437235 · Received August 21, 2020

    Report

    Report Number
    3004189859-2020-00004
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    August 14, 2020
    Report Date
    September 29, 2020
    Manufacturer
    ZONARE MEDICAL SYSTEMS, INC
    Product Code
    DRJ
    UDI-DI
    05415067013361
    PMA / PMN Number
    K151175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RETURNED LOGS CONFIRMED THE REPORTED EVENT OF THE TRANSDUCER NOT BEING SELECTED AND A BLACK SCREEN BEING NOTED. RESULTS OF THE INVESTIGATION DETERMINED THE CAUSE OF THE MALFUNCTION WAS THE MODULE. THE MODULE EVALUATION INDICATED THE POWER BOARD NEEDED TO BE REPLACED. THE DEVICE HISTORY RECORD (DHR) FOR THE UNIT INVOLVED IN THE REPORT WAS REVIEWED, NO ISSUES WERE NOTED. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE CAUSE FOR THE REPORTED EVENT WAS DUE TO THE POWER BOARD.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE TRANSDUCER COULD NOT BE SELECTED, A BLACK SCREEN WAS NOTED AND THE CASE WAS CANCELLED. THERE WERE NO CONSEQUENCES TO THE PATIENT AND THE CASE WAS RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903355 VIEWMATE Z ULTRASOUND CONSOLE WBATTERY ZS3 SYSTEM, SIGNAL ISOLATION DRJ ZONARE MEDICAL SYSTEMS, INC H701336 6047587 05415067013361

    Patients

    Seq Age Sex Outcome Treatment
    1 Other