BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRINTER, LARGE FORMAT, HNL, 220V

    MDR report key: 2398445 · Received November 28, 2011

    Report

    Report Number
    1222895-2011-00035
    Event Type
    Malfunction
    Date Received
    November 28, 2011
    Report Date
    November 28, 2011
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PLUGGED THE 110 VOLT (110V) PRINTER W/O USING A POWER CONVERTER INTO A 220 VOLT (220V) OUTLET. THE CUSTOMER SAW THE 220V STICKER ON THE OUTSIDE BOX OF THE PRINTER AND PLUGGED THE PRINTER INTO A 220 POWER STRIP WITH ADAPTER PLUGS THAT THE CUSTOMER HAD ON SITE TO CONVERT THE U.S. THREE PRONG PLUG OF THE 110V PRINTER TO THEIR 220 TWO PIN CONFIGURATION. IT WAS REPORTED THAT A "PUFF OF SMOKE" WAS OBSERVED AND THAT "SOMETHING SMELLED BAD". THE POWER SUPPLY OF THE PRINTER WAS DAMAGED. THERE WAS NO PT CONTACT, NO PT INJURY, AND NO USER INJURY. THE PRODUCT PROBLEM OCCURRED DURING TESTING OF THE PRODUCT. THE CUSTOMER WAS NOT AWARE THAT A TRANSFORMER WAS TO BE USED WITH THE 110V PRINTER SINCE THE OUTSIDE BOX OF THE 110V PRINTER WAS LABELED "PRINTER, LARGE FORMAT WITH PARALLEL CABLE, 220V" (REF: (B)(4)). THE TRANSFORMER WAS PACKAGED AND SHIPPED IN A SEPARATE BOX FROM THE PRINTER. IT WAS REPORTED THAT THE CUSTOMER ASSUMED THAT THE PRINTER INSIDE THE 220V LABELED BOX WAS A 220V PRINTER WITH A POWER SUPPLY THAT WOULD SUPPORT 110-240V.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRINTER, LARGE FORMAT, HNL, 220V NA JQP INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1