BEUDAMED
    FDA Adverse Event Death Summary report: Y

    NONIN MEDICAL MODEL 7500

    MDR report key: 17135713 · Received June 15, 2023

    Report

    Report Number
    2183646-2023-00001
    Event Type
    Death
    Date Received
    June 15, 2023
    Date of Event
    April 25, 2023
    Report Date
    June 15, 2023
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    UDI-DI
    00833166009798
    PMA / PMN Number
    K080255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NONIN WAS CONTACTED ABOUT RETRIEVING THE MEMORY DATA OUT OF THE MODEL 7500 PULSE OXIMETER. IT WAS COMMUNICATED TO US FROM THE PERSON WHO CONTACTED US, THE (MOTHER) COMMUNICATED THAT THE CHILD/PATIENT IS UNDER NURSE CARE AND DURING MONITORING THE DEVICE ALARMED BUT ALLEGEDLY THE NURSE DISMISSED THE ALARM. THERE WAS A SHIFT CHANGE IN THE NURSES AND THE NEW NURSE ENDED UP CALLING 911. THERE IS NO ALLEGATION OF ANY DEVICE MALFUNCTION. NONIN RECEIVED THE DEVICE AS RECOMMENDED SO WE COULD DO THE MEMORY DOWNLOAD FOR THE MOTHER AS REQUESTED. WE ALSO DID AN INVESTIGATION BY INSPECTING THE DEVICE, PERFORMING FUNCTIONAL TESTING AND PERFORMANCE TESTING. THE DEVICE DATE AND TIME WAS NOT SET. THE DEVICE PARAMETERS WERE NOT SET AND WERE IN DEFAULT MODE. THE SENSOR THAT WAS UTILIZED IS NOT AN APPROVED SENSOR AND IS AN OFF BRAND SENSOR THAT NONIN DOES NOT MANUFACTURE. MODEL 7500 IFU STATES IN THE WARNING SECTION, "TO PREVENT IMPROPER PERFORMANCE AND/OR PATIENT INJURY, VERIFY COMPATIBILITY OF THE MONITOR, SENSOR(S), AND ACCESSORIES BEFORE USE." ALSO, IT STATES IN THE WARNING SECTION, "TO AVOID PATIENT INJURY, USE ONLY NONIN-BRANDED PURELIGHT® PULSE OXIMETER SENSORS. THESE SENSORS ARE MANUFACTURED TO MEET THE ACCURACY SPECIFICATIONS FOR NONIN PULSE OXIMETERS. USING OTHER MANUFACTURERS' SENSORS CAN RESULT IN IMPROPER PULSE OXIMETER PERFORMANCE." FUNCTIONAL TESTING SHOWED THE DEVICE FUNCTIONING AS INTENEDED INCLUDING ALARMS. PERFORMANCE TESTING OF THE DEVICE WAS PERFORMED (LOW PERFUSION PER ISO 80601-2-61: 2017 SUB-CLAUSES 201.12.1.103 & 201.12.1.104) RESULTING IN A PASS. NONIN WILL CONTINUE MONITORING FOR SIMILAR EVENTS TO ENSURE THE DEVICE CONTINUES TO PERFORM AS EXPECTED.

    Description of Event or Problem · 0

    NONIN WAS CONTACTED ABOUT RETRIEVING THE MEMORY DATA OUT OF THE MODEL 7500 PULSE OXIMETER. IT WAS COMMUNICATED TO US FROM THE PERSON WHO CONTACTED US, THE (MOTHER) COMMUNICATED THAT THE CHILD/PATIENT IS UNDER NURSE CARE AND DURING MONITORING THE DEVICE ALARMED BUT ALLEGEDLY THE NURSE DISMISSED THE ALARM. THERE WAS A SHIFT CHANGE IN THE NURSES AND THE NEW NURSE ENDED UP CALLING 911. THERE IS NO ALLEGATION OF ANY DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746928 NONIN MEDICAL MODEL 7500 PULSE OXIMETER DQA NONIN MEDICAL, INC. 7500 00833166009798

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death