BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN SOFT SENSOR 8000SM

    MDR report key: 6048304 · Received October 21, 2016

    Report

    Report Number
    3007389703-2016-00005
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    NONIN MEDICAL INC.
    Product Code
    DQA
    PMA / PMN Number
    K092101
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NOX MEDICAL FILE IDENTIFICATION #(B)(4). PATIENT DATA TRACEABILITY RELYING ON (B)(4) FILES AND (B)(4) IDENTIFICATION USED. NOX MEDICAL IS A REPACKAGER OF THE NONIN SOFT SENSOR 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 IS GOING TO BE SENT DIRECTLY FROM (B)(4) (THE IMPORTER AND DISTRIBUTOR) TO NONIN MEDICAL (THE FINISHED DEVICE LEGAL MANUFACTURER) FOR FURTHER EVALUATION ACCORDING TO CAREFUSION PROCESSES. 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 SOFT SENSOR PERFORMED BY NOX MEDICAL. ANY FURTHER REPORTS WILL COME FROM NONIN MEDICAL, THE FINISHED DEVICE MANUFACTURER. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THEIR PATIENT WAS WEARING THE NONIN 3150 PULSE OXIMETER THE PATIENT REPORTED A BUMP AND BURN ON THEIR LEFT FINGER. THE PATIENT HAS NOT BEEN SEEN BY ANY MEDICAL PROFESSIONAL ABOUT THE BURN TO DATE. THE CUSTOMER BELIEVES THAT THEIR PATIENT'S ISSUE WAS DUE TO THE RED LIGHT IN THE FINGER PROBE. THE DEVICE WAS RETURNED TO THE CUSTOMER BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698871 NONIN SOFT SENSOR 8000SM REUSABLE SOFT PULSE OXIMETER SENSOR DQA NONIN MEDICAL INC. 8000SM

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other NONIN 3150 OXIMETER SN: (B)(4)| NOX T3 SYSTEM SN: (B)(4)