BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABI STUDIES

    MDR report key: 25067532 · Received May 4, 2026

    Report

    Report Number
    25067532
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 9, 2026
    Manufacturer
    PARKS MEDICAL
    Product Code
    JOP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE ABI [ANKLE-BRACHIAL INDEX] STUDIES AT [REDACTED] WILL NOT HAVE IMAGES ATTACHED TO THEM. THERE ARE TWO PATIENTS I HAD [REDACTED] WITH ABI'S TODAY. UNFORTUNATELY, ALL THE INFORMATION THE MACHINE UTILIZES TO CONNECT TO LAUREL BRIDGE/SYNAPSE WAS DELETED SOMEHOW. US INSTRUMENTS AND BIOMED WERE BOTH CONTACTED. [REDACTED], OUR BIOMED TECHNICIAN, IS GOING TO LOOK INTO THIS MATTER TOMORROW. AS SOON AS HE RESOLVES THE ISSUES, HE WILL LET ME KNOW. I WILL TALK HIM THROUGH SENDING THE IMAGES TO SYNAPSE AND CONFIRMING THEY ARE IN SYNAPSE. AS SOON AS I AM SURE THEY ARE IN SYNAPSE, I WILL LET YOU KNOW. I AM SORRY FOR ANY INCONVENIENCE. [REDACTED] IS VERY CERTAIN THIS ISSUE WILL BE CORRECTED TOMORROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323987 ABI STUDIES TRANSDUCER, ULTRASONIC JOP PARKS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other