BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDSENSE MEDICAL AB

    MDR report key: 24764563 · Received April 1, 2026

    Report

    Report Number
    MW5186301
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Report Date
    March 26, 2026
    Manufacturer
    REDSENSE MEDICAL AB
    Product Code
    ODX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) MEDICAL CARE WAS NOTIFIED VIA FAX THAT DEVICE WAS LATE IN ALARMING AFTER A BLOOD LEAK (~1 MIN). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812354 REDSENSE MEDICAL AB AUTONOMOUS EXTRACORPOREAL BLOOD LEAK DETECTOR/ALARM ODX REDSENSE MEDICAL AB RA-1-RA 201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown