BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BISPECTRAL INDEX MONITOR

    MDR report key: 23943671 · Received January 2, 2026

    Report

    Report Number
    MW5181563
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Report Date
    December 23, 2025
    Manufacturer
    UNK
    Product Code
    OLW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE CALLER STATED THAT THEY HAD A BIS MONITOR PART NUMBER 185-1014-GE THAT HAD A CABLE THAT WOULD NOT CONNECT FULLY TO THE DEVICE SO THE SYSTEM WAS NOT WORKING. TSS DID NOT ASK FOR ANY SPECIFIC DETAILS AS THE SYSTEM IS NOT AN MDT NEURO SYSTEM. TSS TRANSFERRED THE CALLER TO THE CORRECT DIVISION FOR SUPPORT. 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
    11883 BISPECTRAL INDEX MONITOR NDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE OLW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown