BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONIN MODEL 3150

    MDR report key: 4184013 · Received October 14, 2014

    Report

    Report Number
    2183646-2014-00003
    Event Type
    Other
    Date Received
    October 14, 2014
    Date of Event
    August 29, 2014
    Report Date
    October 10, 2014
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A RESIDUE ON THE RETURNED DEVICE WHICH WAS ANALYZED TO BE BATTERY ACID FROM (B)(6) CELLS CONTAINING POTASSIUM HYDROXIDE WHICH IS A KNOWN SKIN IRRITANT. THE BATTERY WAS NOT RETURNED. THE OPERATION OF THE DEVICE DOES NOT INDICATE A CAUSE FOR THE BATTERIES TO FAIL. THE OPERATING CURRENT WAS TESTED TO BE AS SPECIFIED, THERE WAS NO ELEVATED TEMPERATURES ON THE DEVICE THAT COULD CAUSE A BURN. WHEN THE PT REPLACED THE BATTERIES SHE USED THE DEVICE FOR THE REMAINDER OF THE NIGHT WITH NO FURTHER HARM TO HERSELF. THE MANUAL HAS THE FOLLOWING CAUTION REGARDING BATTERY LEAKAGE: "BATTERIES MAY LEAK OR EXPLODE IF USED OR DISPOSED OF IMPROPERLY. REMOVE BATTERIES IF THE DEVICE WILL BE STORED FOR MORE THAN 30 DAYS. DO NOT USE DIFFERENT TYPES OF BATTERIES AT THE SAME TIME. DO NOT MIX FULLY CHARGED AND PARTIALLY CHARGED BATTERIES AT THE SAME TIME. THESE ACTIONS MAY CAUSE THE BATTERIES TO LEAK".

    Description of Event or Problem · 1

    THE PT RECEIVED A BURN ON HER WRIST FROM THE UNIT. (BATTERY - (B)(6) PRO CELLS FROM AN UNOPENED PACKAGE) BATTERY COMPARTMENT WAS WET AND SHOWED CORROSION. CUSTOMER CHANGED BATTERIES AND WORE IT ON THE OTHER WRIST AND DID NOT RECEIVE ANY TYPE OF BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649963 NONIN MODEL 3150 OXIMETER DQA NONIN MEDICAL, INC. 3150

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other