BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONIN WRISTOX2 PULSE OXIMETER

    MDR report key: 5751206 · Received June 27, 2016

    Report

    Report Number
    3007389703-2016-00003
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 2, 2016
    Manufacturer
    NONIN MEDICAL INC.
    Product Code
    DQA
    PMA / PMN Number
    K102350
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT DATA TRACEABILITY RELYING ON (B)(4) FILES AND (B)(4) IDENTIFICATION USED. 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 HAS BEEN SENT DIRECTLY FROM (B)(4) (THE IMPORTER AND DISTRIBUTOR) TO NONIN MEDICAL (THE FINISHED DEVICE LEGAL MANUFACTURER) FOR FURTHER EVALUATION. NOTE THAT THE NONIN 3150 PULSE OXIMETER SN: (B)(4) WAS REPACKAGED WITH NOX T3 SYSTEM SN: (B)(4).THIS IS NOT THE NOX T3 SYSTEM REPORTED BY THE INITIAL REPORTER (T3 SYSTEM THE INITIAL REPORTER REPORTED HAS SN: (B)(4)). 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, THE FINISHED DEVICE MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE TROUBLESHOOTING, A DIFFERENT ISSUE WITH (B)(4) TECHNICAL SUPPORT, THE DEVICE BECAME VERY HOT, SHUTDOWN, AND WOULD NOT POWER ON AGAIN. THE CUSTOMER REPORTED THAT THEY HAD JUST CHANGED THE BATTERIES IN THE DEVICE APPROXIMATELY 30 MINUTES PRIOR TO THE OCCURRENCE OF THE REPORTED INCIDENT. THE CUSTOMER STATED THAT THEY COULD SMELL SOMETHING THAT SMELLED LIKE "BURNT PLASTIC" HOWEVER THE CUSTOMER DID NOT NOTE ANY AREA ON THE DEVICE THAT APPEARED TO BE BURNED. THE CUSTOMER THEN STATED THAT SHE REMOVED THE BATTERIES AND SAT THE DEVICE ASIDE UNTIL IT COOLED DOWN. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT AND NO REPORT OF SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406047 NONIN WRISTOX2 PULSE OXIMETER WRIST-WORN PULSE OXIMETER DQA NONIN MEDICAL INC. MODEL 3150

    Patients

    Seq Age Sex Outcome Treatment
    1