BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BKSPECTO ULTRASOUND SYSTEM

    MDR report key: 15502864 · Received September 29, 2022

    Report

    Report Number
    15502864
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    May 20, 2022
    Report Date
    September 22, 2022
    Manufacturer
    BK MEDICAL APS
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ULTRASOUND WAS IN THE ROOM AND HAD BEEN USED PRIOR TO THIS SURGERY AND WORKED FINE. PATIENT CAME TO ROOM, WAS PUT UNDER ANESTHESIA AND WAS ASLEEP. ULTRASOUND MACHINE HAD AN ERROR CODE. REP AND TECH SUPPORT CONTACTED. THIS WAS AN UNRECOVERABLE CODE. OR CASE THEN CANCELLED DUE TO EQUIPMENT MALFUNCTION. PATIENT WOKE UP AND TAKEN TO PACU. NO HARM TO THE PATIENT. PROCEDURE TO BE DONE: TRANSPERINEAL PROSTATE BIOPSY. PROCEDURE CANCELLED. WENT TO THE VENDOR. RETURNED TO SERVICE BY VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2933886 BKSPECTO ULTRASOUND SYSTEM TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BK MEDICAL APS 1300-S5

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA Male