BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPSENSE

    MDR report key: 8707034 · Received June 18, 2019

    Report

    Report Number
    8707034
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    December 28, 2018
    Report Date
    June 14, 2019
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOMED CHECKED THE UNIT, WAS WORKING FINE IN FACT USED IN ANOTHER ROOM. THE UNIT GOT MOVED TO ANOTHER CATH LAB ROOM AND REPORTED NOT WORKING THERE. BIOMED TECH WILL RE-CAL/CHECK THE UNIT JUST TO MAKE SURE. USER ERROR IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500630 RESPSENSE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK NONIN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29200 DA