BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDSENSE ALARM SYSTEM

    MDR report key: 22029855 · Received May 15, 2025

    Report

    Report Number
    MW5170452
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Report Date
    May 13, 2025
    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

    PLEASE NOTE THE BELOW COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY (B)(6). IT WAS REPORTED TO (B)(6) VIA FAX REGARDING A REDSENSE ALARM ISSUE: ALARM DID NOT SOUND EVEN THOUGH THERE WAS BLOOD ON THE PATCH. 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
    1881395 REDSENSE ALARM SYSTEM AUTONOMOUS EXTRACORPOREAL BLOOD LEAK DETECTOR/ALARM ODX REDSENSE MEDICAL AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown