BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN WRISTOX2 PULSE OXIMETER

    MDR report key: 7056729 · Received November 23, 2017

    Report

    Report Number
    3007389703-2017-00001
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    October 30, 2017
    Report Date
    November 22, 2017
    Manufacturer
    NONIN MEDICAL INC.
    Product Code
    DQA
    PMA / PMN Number
    K102350
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOX MEDICAL IS A REPACKAGER OF THE NONIN 3150 PULSE OXIMETER, THAT IS INCLUDED IN THE NOX T3 SYSTEM. THE LEGAL MANUFACTURER OF THE FINISHED DEVICE IS NONIN MEDICAL INC. THAT HAS BEEN NOTIFIED OF THE REPORTED EVENT. THE SUSPECTED DEVICE WILL BE SENT DIRECTLY FROM (B)(4) (THE IMPORTER AND DISTRIBUTOR) TO NONIN MEDICAL (THE FINISHED DEVICE LEGAL MANUFACTURER) FOR FURTHER EVALUATION. NOX MEDICAL HAS EVALUATED THE INFORMATION RELATED TO THIS REPORTED EVENT AND CAME TO THE CONCLUSION THAT THE INCIDENT IS NOT RELATED TO THE REPACKAGING OF THE NONIN 3150 PULSE OXIMETER PERFORMED BY NOX MEDICAL. ANY FURTHER REPORTS WILL COME FROM NONIN MEDICAL INC. THE FINISHED DEVICE LEGAL MANUFACTURER).

    Description of Event or Problem · 1

    DURING A HOME SLEEP TEST WHILE THE PATIENT WAS WEARING THE NONIN PULSE OXIMETER UNIT, THE BATTERIES APPARENTLY LEAKED BATTERY ACID OUT OF THE BATTERY COMPARTMENT ONTO THE PATIENT SKIN. THIS WHITE CORROSIVE SUBSTANCE BURNED APPROXIMATELY A QUARTER COIN SIZE BURN ON THE PATIENT RESULTING IN THE PATIENT´S SKIN PEELING OFF FROM THE BURN. THE PATIENT DID NOT NOTICE THE ISSUE UNTIL HE WOKE UP. HE STATED THAT HE FELT A TINGLING IRRITATION ON HIS WRIST. WHEN HE REMOVED THE NONIN PULS OXIMETER, THERE WAS A WHITE SUBSTANCE ON HIS WRIST AND LEAKAGE COMING OUT OF THE BATTERY COMPARTMENT DOOR. THE PATIENT DOES NOT RECALL ANY MOISTURE OCCURRING TO THE UNIT (WASHING HANDS, ETC.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834848 NONIN WRISTOX2 PULSE OXIMETER WRIST-WORN PULSE OXIMETER DQA NONIN MEDICAL INC. MODEL 3150

    Patients

    Seq Age Sex Outcome Treatment
    1 Other