BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONIN PULSE OXIMETER

    MDR report key: 11124728 · Received January 6, 2021

    Report

    Report Number
    2183646-2021-00001
    Event Type
    Death
    Date Received
    January 6, 2021
    Date of Event
    November 23, 2020
    Report Date
    January 6, 2021
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    UDI-DI
    00833166009798
    PMA / PMN Number
    K080255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AN INCIDENT WAS REPORTED THAT A PATIENT WENT INTO CARDIAC ARREST AT THEIR HOME, WAS THEN TRANSPORTED TO THE EMERGENCY ROOM AND SUBSEQUENTLY PASSED AWAY. A MODEL 7500 PULSE OXIMETER WAS PRESENT AT THE PATIENT'S HOME AT THE TIME OF CARDIAC ARREST. AT THE TIME THAT THE INCIDENT WAS REPORTED, THERE WAS NO INDICATION THAT THE MODEL 7500 PULSE OXIMETER CAUSED OR CONTRIBUTED TO PATIENT INJURY OR DEATH. IT WAS REPORTED THAT THE INFANT PATIENT HAD UNDERLYING HEALTH CONDITIONS AND WAS ON A VENTILATOR AT THE TIME OF CARDIAC ARREST. NONIN MEDICAL REQUESTED THE MODEL 7500 PULSE OXIMETER BE RETURNED FOR EVALUATION TO CONFIRM THAT THE DEVICE WAS OPERATING ACCORDING TO SPECIFICATION. THE DME RECEIVED THE EQUIPMENT FROM THE FACILITY BUT HAS DECLINED TO RETURN THE DEVICE TO NONIN MEDICAL PENDING THE DME'S LEGAL INVESTIGATION OF THE EVENT AS A WHOLE. AT THIS TIME, THERE HAS BEEN NO INDICATION OR ALLEGATION OF DEVICE MALFUNCTION CONTRIBUTING TO THE REPORTED EVENT. NONIN MEDICAL REMAINS IN CLOSE CONTACT WITH THE DME AND WILL CONTINUE MONITORING FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.

    Description of Event or Problem · 1

    AN INCIDENT WAS REPORTED THAT A PATIENT WENT INTO CARDIAC ARREST AT THEIR HOME, WAS THEN TRANSPORTED TO THE EMERGENCY ROOM AND SUBSEQUENTLY PASSED AWAY. A MODEL 7500 PULSE OXIMETER WAS PRESENT AT THE PATIENT'S HOME AT THE TIME OF CARDIAC ARREST. AT THE TIME THAT THE INCIDENT WAS REPORTED, THERE WAS NO INDICATION THAT THE MODEL 7500 PULSE OXIMETER CAUSED OR CONTRIBUTED TO PATIENT INJURY OR DEATH. IT WAS REPORTED THAT THE INFANT PATIENT HAD UNDERLYING HEALTH CONDITIONS AND WAS ON A VENTILATOR AT THE TIME OF CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21551 NONIN PULSE OXIMETER PULSE OXIMETER DQA NONIN MEDICAL, INC. 7500 00833166009798

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Death