BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPARRAY

    MDR report key: 21220308 · Received January 22, 2025

    Report

    Report Number
    MW5165151
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 16, 2025
    Manufacturer
    MEDTRONIC / EDAN INSTRUMENTS, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ON RESPARRAY PULSE OX MONITOR, WHEN MONITOR STOPPED PICKING UP READING FOR PATIENT'S PULSE AND OXYGEN LEVEL, THE DEVICE DID NOT SEND OUT AN ALARM THAT WAS NOTICEABLE TO STAFF TO IMMEDIATELY RESPOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606039 RESPARRAY MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX MEDTRONIC / EDAN INSTRUMENTS, INC. RESPARRAYAHA01

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other