BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN MODEL 7500 DIGITAL PULSE OXIMETER

    MDR report key: 11322943 · Received February 12, 2021

    Report

    Report Number
    2183646-2021-00002
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    November 10, 2020
    Report Date
    February 12, 2021
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K071285
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AN INCIDENT WAS REPORTED THAT A PATIENT'S FINGER WAS BURNED DURING AN MRI KNEE SCAN WHILE BEING MONITORED BY A MODEL 7500 PULSE OXIMETER (NON-MRI COMPATIBLE) ON THE AFFECTED FINGER. IT WAS REPORTED THAT A PHYSICIAN DIAGNOSED THE INJURY AS A FULL THICKNESS BURN. AFTER BEING CONTACTED BY THE HOSPITAL ABOUT THE REPORTED INCIDENT, NONIN'S LOCAL DISTRIBUTOR TEAM VISITED THE CUSTOMER SITE TO INVESTIGATE THE CAUSE OF THE REPORTED INJURY. INVESTIGATION OF THIS EVENT DETERMINED THAT THE MODEL 7500 PULSE OXIMETER USED ON THE PATIENT'S FINGER IS NOT MRI COMPATIBLE, THUS WAS INCORRECTLY USED PER THE CONTRAINDICATIONS OF THE DEVICE. IT WAS REPORTED THAT THE PATIENT WAS SEDATED AND ON A VENTILATOR DURING THE MRI SCAN, THEREFORE THE FINGER BURN WAS NOT IDENTIFIED UNTIL AFTER THE PATIENT WAS REMOVED FROM THE MRI SYSTEM. MEDICAL INTERVENTION FOR THE PATIENT AS A RESULT OF THE INJURY WAS REPORTED AS CONSERVATIVE MANAGEMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NONIN'S LOCAL DISTRIBUTOR TEAM HAS COMMUNICATED TO THE HOSPITAL THE NEED TO USE AN MRI COMPATIBLE PULSE OXIMETER IN MR ENVIRONMENTS TO AVOID ASSOCIATED HAZARDS. INVESTIGATION OF THIS INCIDENT CONFIRMED THAT THE INJURY WAS CAUSED BY THE HOSPITAL USING THE WRONG (NON-MRI COMPATIBLE) OXIMETER DURING THE MRI SCAN. THE HOSPITAL HAS SINCE PURCHASED AN MRI-COMPATIBLE PULSE OXIMETER TO AVOID SUCH INCIDENTS IN THE FUTURE.

    Description of Event or Problem · 1

    AN INCIDENT WAS REPORTED THAT A PATIENT'S FINGER WAS BURNED DURING AN MRI KNEE SCAN WHILE BEING MONITORED BY A MODEL 7500 PULSE OXIMETER (NON-MRI COMPATIBLE) ON THE AFFECTED FINGER. IT WAS REPORTED THAT A PHYSICIAN DIAGNOSED THE INJURY AS A FULL THICKNESS BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222029 NONIN MODEL 7500 DIGITAL PULSE OXIMETER PULSE OXIMETER DQA NONIN MEDICAL, INC. 7500

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other OPTIMA MR360 NUCLEAR MRI| PURESAT SPO2 PULSE OXIMETER SENSOR