BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN WRISTOX2 PULSE OXIMETER

    MDR report key: 5676134 · Received May 24, 2016

    Report

    Report Number
    3007389703-2016-00001
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    April 21, 2016
    Report Date
    April 21, 2016
    Manufacturer
    NONIN MEDICAL INC.
    Product Code
    DQA
    PMA / PMN Number
    K102350
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT DATA TRACEABILITY RELYING ON (B)(4) FILES AND (B)(4) IDENTIFICATION USED. (B)(4) 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 HAS BEEN SENT DIRECTLY FROM (B)(4) (THE IMPORTER AND DISTRIBUTOR) TO NONIN MEDICAL (THE FINISHED DEVICE LEGAL MANUFACTURER) FOR FURTHER EVALUATION. (B)(4) 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 (B)(4). ANY FURTHER REPORTS WILL COME FROM NONIN MEDICAL THE FINISHED DEVICE MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONE OF THEIR PATIENTS COMPLAINED OF A BURNING SENSATION AFTER WEARING THE NONIN 3150 PULSE OXIMETER FOR APPROXIMATELY TWO HOURS DURING AN IN HOME SLEEP STUDY. THE PATIENT REMOVED THE DEVICE AND FOUND THAT THE AREA ON THE PATIENT'S SKIN UNDER WERE THE BATTERIES ARE INSERTED HAD REDNESS AND A BLISTER. THE PATIENT WENT TO URGENT CARE AND WAS TREATED WITH AN ANTIBIOTIC AND A CREAM FOR THE BURN. THE DEVICE WAS RETURNED TO THE CUSTOMER BY THE PATIENT AND THE PATIENT WAS SENT TO A CLINIC FOR THE COMPLETION OF THE SLEEP STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332292 NONIN WRISTOX2 PULSE OXIMETER WRIST-WORN PULSE OXIMETER DQA NONIN MEDICAL INC. MODEL 3150

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other NOX T3 SYSTEM SN: (B)(4)