BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S19 GEN2 (N)SPO2 4IP IEC AM12M LAN

    MDR report key: 24503234 · Received March 3, 2026

    Report

    Report Number
    1316463-2026-00012
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 5, 2026
    Report Date
    February 5, 2026
    Manufacturer
    MORTARA INSTRUMENT
    Product Code
    DSI
    UDI-DI
    0000732094321449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A DUPLICATE OF MANUFACTURER REPORT NUMBER 2183461-2026-00005. ALL INFORMATION CAN BE FOUND UNDER MANUFACTURER REPORT NUMBER 2183461-2026-00005. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON INSPECTION, THE BAXTER TECHNICIAN CONFIRMED THE REPORTED ISSUE AND FOUND THE PCBA BOARD WAS FAULTY. THE SURVEYOR S19 PATIENT MONITORS ARE SMALL, LIGHTWEIGHT PATIENT MONITORS DESIGNED TO ACQUIRE PHYSIOLOGICAL WAVEFORMS AND PARAMETERS, AND TO TRANSMIT THIS DATA TO THE SURVEYOR CENTRAL MONITORING STATION. THE ¿BED TO BED COMMUNICATION¿ FEATURE ALLOWS REMOTE VIEWING OF MONITORS WHEN CONNECTED TO A SURVEYOR CENTRAL STATION. THE WELCH ALLYN SURVEYOR PATIENT MONITOR IS A PRESCRIPTION DEVICE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS IN ALL AREAS OF A HEALTHCARE FACILITY. THE BAXTER TECHNICIAN REPLACED THE PCBA AND PERFORMED FUNCTIONAL TESTING OF THE DEVICE TO RESOLVE THE REPORTED ISSUE. ALTHOUGH THERE WAS NO ADVERSE EVENT REPORTED, IF THE REPORTED MALFUNCTION WERE TO RECUR AND THE S19 WAS BEING USED AS STANDALONE DEVICE, IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THIS WERE TO RECUR.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED UNIT WAS SHUTTING DOWN DURING USE, THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED UNIT WAS SHUTTING DOWN DURING USE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498 S19 GEN2 (N)SPO2 4IP IEC AM12M LAN DETECTOR AND ALARM, ARRHYTHMIA DSI MORTARA INSTRUMENT SUR19-XDH-XXXAX 0000732094321449

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown