BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 9600

    MDR report key: 5153801 · Received October 15, 2015

    Report

    Report Number
    3022472-2015-00031
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 24, 2015
    Manufacturer
    VERATHON MEDICAL
    Product Code
    ITX
    PMA / PMN Number
    K082456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES TESTED THE UNIT AND CONFIRMED THE INACCURATE READINGS WITH 0ML PROBE READINGS AND <3.0 CM AORTA READINGS. CAPA (B)(4) WAS IMPLEMENTED TO IMPROVE THE WIRE CRIMPING PROCESS IN MANUFACTURE OF THE CABLE. THIS ADDRESSED THE PROBLEM WITH SHORTING AND STRESS ON PINS WITHIN THE PROBE. PRINTING OF STRANGE IMAGES COULD NOT BE CONFIRMED. ADDITIONAL REPAIRS WERE CONDUCTED TO REPLACE THE CRACKED TOP AND BOTTOM PROBE COVER, EVALUATED TO BE THE RESULT OF CUSTOMER USE. THE DATA COLLECTION MODULE AND PRINTED CIRCUIT BOARD ASSEMBLY WERE REPLACED AND THE REPAIRED UNIT RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE DEVICE IS SHOWING INACCURATE AORTA SCANS AND IS PRINTING STRANGE IMAGES. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683047 BVI 9600 TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX VERATHON MEDICAL BVI 9600

    Patients

    Seq Age Sex Outcome Treatment
    1