BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UBIT-IR300 INFRARED SPECTROPHOTOMETER

    MDR report key: 1645633 · Received March 12, 2010

    Report

    Report Number
    3005622096-2010-00001
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 2, 2010
    Report Date
    March 2, 2010
    Manufacturer
    OTSUKA ELECTRONICS CO., LTD.
    Product Code
    JJQ
    PMA / PMN Number
    K013371
    Removal / Correction Number
    Z-1749-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS PRELIMINARILY INVESTIGATED BY PERSONNEL FROM (B)(4), THE PRODUCT DISTRIBUTOR. (B)(4) PERSONNEL OBTAINED PRELIMINARY INFORMATION VIA TELEPHONE ON (B)(6) 2010 AND CONDUCTED A LIMITED INSPECTION OF THE INSTRUMENT AT THE (B)(6) ON (B)(6) 2010. NO EVIDENCE OF BURNING, MELTING, DISCOLORATION, OR DELAMINATION ON ANY OF THE UBIT-IR2300 OUTSIDE SURFACES WAS OBSERVED. NO EVIDENCE OF BURNING, MELTING, DISCOLORATION OR DELAMINATION WAS OBSERVED ON ANY OF THE INTERNAL COMPONENTS OR INSULATED WIRING, WITHIN THE UNCOVERED TOP PORTION OF THE UBIT-IR300. THE INITIAL REPORTER TOLD (B)(4) PERSONNEL DURING THE PRELIMINARY INVESTIGATIONS THAT A "LOW AIR FLOW" ERROR OCCURRED PREVIOUSLY BUT WAS RESOLVES AFTER VACUUMING THE BOTTOM EXTERNAL FILTERS. SPECIAL CLOSE-UP (OPTICALLY-UNAIDED) ATTENTION USED TO LOOK FOR ANY EVIDENCE OF BURNED OR DISCOLORED DUST IN THE UPPER COMPARTMENT, BUT NONE WAS FOUND. LARGE AMOUNTS AND CLUMPS OF GRAY-THREAD-LIKE DUST WAS EASILY OBSERVED (AND PHOTOGRAPHED) THROUGHOUT THE INSIDE OF THE TOP PORTION OF THE UBIT-IR300, WITH THE LARGEST CONCENTRATIONS OBSERVED IN AREAS THAT WERE ADJACENT TO THE UNIT'S VENT HOLES. THE INVESTIGATION HAS DETERMINED THAT THIS EVENT IS THE SAME AS ONE THAT OCCURRED IN (B)(6) 2007. THE 2007, EVENT WAS THOROUGHLY INVESTIGATED AND IS THE SUBJECT OF CORRECTION AND REMOVAL (B)(4). CONCLUSION: THE POWER SUPPLY FAILURE THAT OCCURRED ON THE UBIT-IR300 (SERIAL NO.(B)(4)) USED IN (B)(6) ON (B)(6) 2010, IS EXACTLY SAME AS AN INCIDENT IN (B)(6) 2007. THE 2007 EVENT WAS THOROUGHLY INVESTIGATED AND IS THE SUBJECT OF CORRECTION AND REMOVAL (B)(4). (THE INVESTIGATION OF THE PREVIOUS INCIDENT CONCLUDED THAT AN INCIDENT OF THIS TYPE POSED NO FIRE DANGER).

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED ON (B)(6) 2010, WHEN A SMOKE ALARM AT THE CLINIC WAS ACTIVATED THE MORNING OF TUESDAY (B)(6) 2010 AT APPROXIMATELY 7:25 AM. FRONT DESK EMPLOYEE OF (B)(6) SAW/HEARD A "FIRE NOTICE" AND "FIRE BEEP" FROM THE ENTRY KEY PAD AS SHE WAS THE FIRST TO ENTER (B)(6) THAT MORNING. THE CLINIC'S MANAGER REPORTS ON ARRIVAL AT WORK AT ~ 7:30 THAT MORNING, SHE "SAW A CLOUD AND SMELLED SMOKE AND CALLED 911". THE LOCAL FIRE DEPARTMENT RESPONDED (STATION #2, (B)(6)) AND DETERMINED THAT THE SOURCE OF THE SMOKE WAS THE (B)(6). THE FIRE DEPARTMENT'S REPORT STATES, "WE WERE INFORMED BY AN EMPLOYEE OF A PIECE OF EQUIPMENT THAT HAD NOT BEEN OPERATING PROPERLY. THE EQUIPMENT WAS QUICKLY IDENTIFIED AS THE SOURCE OF THE ODOR. IT WAS REMOVED TO THE EXTERIOR OF THE BUILDING." THE REPORT ALSO STATES, "COMMAND ADVISED THERE WAS NO FIRE, BUT A SLIGHT HAZE AND ODOR. AFTER INVESTIGATION, IT WAS DETERMINED A PIECE OF EQUIPMENT WAS THE CAUSE OF THE ODOR." THE FIRE DEPARTMENT REMOVED THE UBIT-IR300 FROM THE PREMISES; IT REMAINED OUTSIDE FOR APPROXIMATELY TWO (2) HOURS BEFORE BEING RETURNED TO THE BUILDING.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NO PATIENT INVOLVED