BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UBIT-IR300 INFRARED SPECTROPHOTOMETER

    MDR report key: 1074037 · Received July 8, 2008

    Report

    Report Number
    3005622096-2008-00001
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 7, 2008
    Manufacturer
    OTSUKA ELECTRONICS CO. LTD.
    Product Code
    JJQ
    PMA / PMN Number
    K013371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT IS CURRENTLY UNDER EVALUATION IN ANOTHER COUNTRY. OBSERVATIONS BY THE SERVICE TECHNICIAN ARE GIVEN BELOW. A FIELD REP VISITED THE SITE IN 2008. AT THAT TIME, A PRELIMINARY INVESTIGATION OF THE INSTRUMENT FOUND NO RESIDUAL DETECTABLE SMELL OF "BURNING". ON OPENING THE COVER OF THE INSTRUMENT, A MODERATE AMOUNT OF DUST WAS OBSERVED IN THE INTERNAL COMPONENTS OF THE UPPER CHASSIS. THE INSTRUMENT WAS POSITION 3 1/4" FROM A WALL ON THE LEFT SIDE, 3" FROM A COMPUTER PRINTER ON THE RIGHT SIDE, AND 2" FROM A WALL IN THE REAR OF THE UNIT, PROVIDING INADEQUATE VENTILATION. THE MANUAL STATES THAT THE INSTRUMENT SHOULD HAVE NO LESS THAN 4" CLEARANCE ALL AROUND THE INSTRUMENT.

    Description of Event or Problem · 1

    ON THE MORNING OF THE EVENT DATE THE MEDICAL TECHNICIAN AT THE PRACTICE REPORTED TO THE BUSINESS MANAGER, A BURNING ELECTRICAL SMELL IN THE HALLWAY. THE SMELL WAS TRACED TO THE UBIT-IR300 IN THE LAB AREA. WHEN THE UBIT-IR300 WAS TURNED OFF, THE SMELL DISSIPATED IN ABOUT 10 MINUTES. NO SMOKE WAS ASSOCIATED WITH THE SMELL. NO USER DISCOMFORT OR INJURY WAS REPORTED. EARLIER THAT DAY, THE UBIT-IR300 HAD DISPLAYED AN ERROR MESSAGE THAT INDICATED THE O2 SENSOR NEEDED TO BE REPLACED. THIS ERROR MESSAGE REQUIRES A SERVICE CALL. THE BUSINESS MANAGER NOTIFIED MERETEK-OAPI CUSTOMER SERVICE ON THE SAME DAY, AND A TECHNICIAN WAS SENT TO INVESTIGATE TWO DAYS LATER. A REPLACEMENT UNIT WAS SENT TO THE FACILITY AND IT ARRIVED THE FOLLOWING DAY. THIS INSTRUMENT WAS THE SUBJECT OF A REPAIR NOTICE. NOTICE OF THE REPAIR HAD BEEN RECEIVED BY THE CUSTOMER. LETTER IS ATTACHED. THE DEFECTIVE UNIT WAS SHIPPED TO MERETEK-OAPI FOR RETURN WHERE A DETAILED INVESTIGATION WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UBIT-IR300 INFRARED SPECTROPHOTOMETER JJQ (SPECTROPHOTOMETER) JJQ OTSUKA ELECTRONICS CO. LTD. UBIT-IR300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1