BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIWAVE INFRARED THERAPY DEVICE

    MDR report key: 3679422 · Received June 26, 2006

    Report

    Report Number
    1055581-2006-00042
    Event Type
    Malfunction
    Date Received
    June 26, 2006
    Date of Event
    May 29, 2006
    Report Date
    June 26, 2006
    Manufacturer
    BIOCARE SYSTEMS, INC
    Product Code
    ILY
    Removal / Correction Number
    CAR #100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS STANDARD IS USED BY UL WHEN TESTING FOR UL 60950-1 APPROVAL FOR WHICH THIS PRODUCT CLAIMS COMPLIANCE. FOR THIS SET OF TESTS, EACH UNIT WAS TESTED IN ACCORDANCE WITH SECTION 43 DIRECT PLUG-IN BLADE SECURENESS TEST OF THE UL 1310 SPECIFICATION. THIS TEST REQUIRES A 201B PULL TEST FOR 2 MINUTES ON EACH INDIVIDUAL BLADE AND THEN ON BOTH BLADES TOGETHER WITH THE UNIT SUPPORTED HORIZONTALLY. THE 201B WEIGHT USED WAS MEASURED AT 20.35LBS ON A CALIBRATED SCALE. ALL UNITS PASSED UL 1310'S DIRECT PLUG-IN BLADE SECURENESS TEST. IN ADDITION TO TESTING THE PRODUCT TO THE UL STANDARD 1310 SECTION 43, A PULL TEST WAS PERFORMED VIA THE CORD WITH THE AC ADAPTER PLUGGED INTO A WALL OUTLET. THIS TEST WAS DONE TO REPLICATE THE INFORMATION PROVIDED FROM THE ORIGINAL COMPLAINT AND ALTHOUGH IT IS CONSIDERED A MISUSE APPLICATION, IT DOES REFLECT A POTENTIAL REAL WORLD SCENARIO. FOR THIS TEST, EACH UNIT WAS PLUGGED INTO AN ORDINARY WALL OUTLET AND PULLED OUT BY THE CORD. THE FORCE USED TO PULL THE UNITS OUT WAS NOT EXCESSIVE (I.E. THE UNIT WAS NOT RIPPED FROM THE WALL VIOLENTLY). THE CORD WAS PULLED WITH A MODERATE, FIRM JERK THAT WAS ENOUGH TO REMOVE THE AC ADAPTER FROM THE WALL OUTLET. EVERY UNIT FAILED ON THE FIRST PULL. THE UNITS THAT WERE SUBJECTED TO A STRAIGHT OR VIRTUALLY STRAIGHT PULL FAILED WITH ONE BLADE BEING COMPLETELY REMOVED FROM THE UNIT AND THE SECOND BLADE BEING EITHER VERY LOOSE MECHANICALLY OR HANGING/DANGLING OUT OF THE AC ADAPTER HOUSING. THE UNITS SUBJECTED TO A 45 DEGREES ANGULAR PULL FAILED WITH BOTH BLADES COMPLETELY REMOVED FORM THE AC ADAPTER. (B)(4).

    Description of Event or Problem · 1

    USER WAS WORKING WITH THE DEVICE (AN EMPLOYEE OF THE MANUFACTURER) WHILE SITTING IN A SWIVEL CHAIR. USER TURNED IN THIS CHAIR FARTHER THAN THE CORD WOULD ALLOW AND THE POWER SUPPLY WAS PULLED FROM THE OUTLET LEAVING BOTH PRONGS FROM THE WALL WART IN THE WALL SOCKET. NO INJURY OR SHOCK OCCURRED AS A RESULT OF THIS EVENT. PRODUCT PROBLEM AND PRODUCT USE ERROR: DURING USE OF THE PRODUCT, USER PULLED THE POWER SUPPLY FROM THE WALL OUTLET BY THE POWER CORD AND NOT THE POWER SUPPLY HOUSING. THE RESULTING FAILURE WAS THAT THE PRONGS OF THE POWER SUPPLY BECAME SEPARATED FROM THE HOUSING AND REMAINED IN THE WALL-OUTLET. IT IS NOTED THAT THE COMPONENT FAILURE IS FOR AN OFF-THE-SHELF ITEM USED IN MANY CONSUMER PRODUCTS. THERE HAVE BEEN A TOTAL OF THREE REPORTED INCIDENTS OF THIS FAILURE MODE AT THIS TIME. THE PRODUCT POWER SUPPLY WAS VISUALLY INSPECTED. IT WAS CONFIRMED THAT THE PRONGS FROM THE POWER SUPPLY WERE DETACHED FROM THE SWAGING LOCATION. OBVIOUS DEFORMATION OF PLASTIC SURROUNDING THE ENTRY POINT OF THE BLADES TO THE HOUSING INDICATES THE UNIT WAS PULLED FORM THE WALL BY THE CORD. THE POWER SUPPLY ITSELF IS A COMMERCIALLY AVAILABLE PRODUCT; AC ADAPTER MODEL (B)(4) MANUFACTURED BY CUI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMIWAVE INFRARED THERAPY DEVICE INFRARED LAMP ILY BIOCARE SYSTEMS, INC LUMIWAVE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR