BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUNDSTAR

    MDR report key: 21761622 · Received April 3, 2025

    Report

    Report Number
    21761622
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    January 27, 2025
    Report Date
    April 1, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT 1 [REDACTED] MFG [MANUFACTURER] PRODUCT CODE: 10439072, LOT: G4155712. DURING PREP OF THE ULTRASOUND CATHETER, THE CATHETER WOULD NOT MAP TO THE PUI. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. EVENT 2 [REDACTED] MFG PRODUCT CODE: 10439072, LOT: G4155200. AFTER PLACED INTO THE PATIENT, THERE WAS A SENSOR ERROR WITH SOUNDSTAR ECO. THIS CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. EVENT 3 [REDACTED] MFG PRODUCT CODE: 10439072, LOT: G4155714. THE SOUNDSTAR ECO ULTRASOUND CATHETER REGISTERED A SENSOR ERROR AFTER PLACED INTO THE PATIENT. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR ULTRASOUND CATHETER, SOUNDSTAR ECO ULTRASOUND CATHETER (PER SITE REPORTER). MFG [MANUFACTURER] NOTIFIED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614795 SOUNDSTAR CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10439072 G4155712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown