BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN WRISTOX2 PULSE OXIMETER

    MDR report key: 5705348 · Received June 8, 2016

    Report

    Report Number
    3007389703-2016-00002
    Event Type
    Injury
    Date Received
    June 8, 2016
    Date of Event
    May 11, 2016
    Report Date
    May 11, 2016
    Manufacturer
    NONIN MEDICAL INC.
    Product Code
    DQA
    PMA / PMN Number
    K102350
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (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) 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 THAT THE DEVICE ON THE WRIST BECAME HOT AROUND 2AM AND THE PATIENT AWOKE TO A BURNING SENSATION AND NOTICED REDNESS ON HIS ARM WITH A SMALL AREA OF WETNESS. HE IMMEDIATELY TOOK OFF THE DEVICE AND NOTED FLUID RESIDUE ON HIS ARM. HE WASHED HIS ARM FOR THREE TO FIVE MINUTES AND THEN APPLIED NEOSPORIN AND A DRESSING TO THE AREA. THE PATIENT THEN WENT BACK TO SLEEP AND WAS AWAKENED TO SLIGHT DISCOMFORT IN THE AREA HE HAD WASHED. THE PATIENT THEN WASHED THE AREA AGAIN AND NOTED A SCAB FORMING. WHEN THE PATIENT WOKE UP LATER THAT DAY HE WENT TO A CLINIC AND WAS TREATED BY A NURSE PRACTITIONER WHO STATED THAT THE PATIENT HAD A SECOND DEGREE BURN FROM THE HEAT OF THE DEVICE. THE BURN WAS IN A RECTANGULAR SHAPE WITH A BLACKISH STAIN, IT WAS APPROXIMATELY 2.5 INCHES BY 0.5 INCHES ON THE ANTERIOR OF THE ARM, APPROXIMATELY 3 INCHES FROM THE WRIST. THE PATIENT´S ARM WAS CLEANED BY NURSE PRACTITIONER AND NEOSPORIN AND A COUPLE OF 2X2 DRESSINGS WERE APPLIED TO THE SITE ALONG WITH COBAN TO SECURE THE DRESSING. THE PATIENT WAS THEN SENT HOME AND INSTRUCTED TO GO TO THE EMERGENCY ROOM IF THEY NOTICED ANY SIGNS OF INFECTION. THE PATIENT HAS SINCE REPORTED THAT THEY ARE HEALING JUST FINE. 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
    361665 NONIN WRISTOX2 PULSE OXIMETER WRIST-WORN PULSE OXIMETER DQA NONIN MEDICAL INC. MODEL 3150

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other NOX T3 SYSTEM SN: (B)(4)