BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UBIT-IR300 INFRARED SPECTROPHOTOMETER

    MDR report key: 2894963 · Received November 13, 2007

    Report

    Report Number
    3005622096-2007-00001
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 2, 2007
    Report Date
    November 9, 2007
    Manufacturer
    OTSUKA ELECTRONICS CO. LTD.
    Product Code
    JJQ
    PMA / PMN Number
    K013371
    Removal / Correction Number
    07-058-CMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF PRELIMINARY INVESTIGATION OF DEVICE INVOLVED - INVESTIGATION ONGOING: THE DEVICE INVOLVED, UBIT-IR300 SPECTROPHOTOMETER, SERIAL NO (B)(4), WAS SHIPPED TO EXPONENT FAILURE ANALYSIS ASSOCIATES ((B)(4)) FOR ANALYSIS AND CAUSE DETERMINATION. OTSUKA ELECTRONICS CO LTD PERSONNEL TRAVELED FROM (B)(4) TO (B)(4) TO MEET WITH EXPONENT AND REVIEW RESULTS TO DATE. A VISUAL INSPECTION OF THE INSTRUMENT SHOWED NO SIGNS OF DAMAGE ON THE EXTERIOR OR INTERIOR OF THE UNIT WHEN THE OUTER COVER WAS REMOVED. ALL VISUAL DAMAGE WAS CONFINED TO THE INSIDE OF THE POWER SUPPLY. THE POWER SUPPLY SHOWED A BUILD UP OF DEBRIS (PRIMARILY DUST). THE POWER SUPPLY COMPONENTS SHOWED SIGNS OF THERMAL AND SMOKE DAMAGE. DAMAGE WITHIN THE POWER SUPPLY WAS LIMITED TO THE INDUCTOR AND SURROUNDING AREA. (B)(4), PROVIDED EXPONENT FAILURE ANALYSIS ASSOCIATES WITH ADD'L UNITS FOR FAILURE SIMULATION AND THE ANALYSIS IS ONGOING. PRELIMINARY WORK INDICATES THE CAUSE OF THE SMOKE WAS OVERHEATING OF THE INDUCTOR DUE TO A BUILD UP OF HEAT CAUSED BY DEBRIS IN THE POWER SUPPLY. INCIDENT SIMULATION CONDUCTED BY OTSUKA ELECTRONICS: OTSUKA ELECTRONICS IN (B)(4) CONDUCTED SIMULATION TESTING OF THE FAILURE BASED ON DESCRIPTION OF THE INCIDENT. TESTS WERE PERFORMED TO SIMULATE FAILURE IN NORMAL AND FAULT CONDITIONS. CONCLUSION: THERE IS NO RISK OF FIRE EVEN IF THE DEBRIS ACCUMULATED IN THE POWER SUPPLY SMOKES. ACCUMULATION OF DEBRIS IS IN PROPORTION TO THE USAGE HOURS AS A WHOLE AND DEGRADATION OF COMPONENTS IN THE POWER SUPPLY COULD POSSIBLY SMOKE. ADD'L INFO FROM IMPORTER REPORT: DATE OF THIS REPORT: (B)(4) 2007, (B)(6). INITIAL FEEDBACK AND CONFIRMATION: ACCORDING TO THE PRACTICE MGR, (B)(6) AND FIREMAN CALLED TO THE SCENE AT 8:41 AM, THERE ARE NO REPORTED INJURIES OR PROPERTY DAMAGE, AND NO FIRE (FLAMES) WERE OBSERVED DURING THE ENTIRE INCIDENT. VISUAL IMPRESSIONS AND EXAMINATION: NO VISUAL EVIDENCE OF FIRE OR SMOKE DAMAGE WAS OBSERVED, EITHER IN THE IMMEDIATE AREA WHERE THE UBIT-IR300 SPECTROPHOTOMETER WAS LOCATED, NOR IN THE ADJOINING HALLWAYS OR ROOMS OF THE CLINIC. NO VISUAL EVIDENCE OF FIRE OR SMOKE DAMAGE (BURNING, MELTING, CHARRING, SMOKE ACCUMULATION, ETC) WAS OBSERVED ON THE OUTSIDE OF THE UBIT-IR300 SPECTROPHOTOMETER UNIT, NOR ON THE INSIDE OF THE UNIT, AFTER (B)(6) REMOVED (ONLY) THE TOP COVER. OLFACTORY (SMELL) IMPRESSION: A DISTINCT SMELL, SIMILAR TO THAT OF BURNING ELECTRICAL INSULATION, WAS DETECTED BY BOTH (B)(6) AROUND, AND ESPECIALLY FROM WITHIN THE UBIT-IR300 SPECTROPHOTOMETER AFTER THE COVER WAS REMOVED. THE SMELL SEEMED TO BE STRONGEST WHEN SNIFFED WITHIN THE UNCOVERED UNIT. CAUSE OF THE COMPLAINT: IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE COMPLAINT DURING THIS SITE VISIT. UBIT-IR300 SPECTROPHOTOMETER: SERIAL NO (B)(4) WAS SUBSEQUENTLY SHIPPED TO EXPONENT FAILURE ANALYSIS ASSOCIATES ((B)(4)) FOR FURTHER ANALYSIS AND CAUSE DETERMINATION. INVESTIGATION IS CONTINUING.

    Description of Event or Problem · 1

    ON THE MORNING OF (B)(6) 2007, THE UBIT-IR300 WAS IN WARM-UP PHASE AND THE STAFF NOTICED THAT IT WAS EMITTING SMOKE. THE BUILDING ALARM WAS ACTIVATED AND STAFF CALLED THE FIRE DEPT. THERE WERE NO INJURIES OR PROPERTY DAMAGE EXCEPT TO THE UBIT-IR300. MORE DETAILS OF THE INCIDENT WERE REPORTED IN THE IMPORTER REPORT NUMBER (B)(4). "STAFF WALKED INTO THE OFFICE AROUND 9:30 TO THE SMELL OF SMOKE. NOTICED THAT THE UBIT MACHINE WAS ON FIRE. FIRE ALARM WENT OFF; ENTIRE BLDG HAD TO BE EVACUATED. NO INJURIES." THE REPORTER CLARIFIED HER STATEMENT THAT THERE WAS NO FIRE AND THE SUBSEQUENT INVESTIGATION CONCLUDED THERE WAS SMOKE BUT NO FIRE.

    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