BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIWAVE INFRARED THERAPY DEVICE

    MDR report key: 3679425 · Received July 5, 2006

    Report

    Report Number
    1055581-2006-00043
    Event Type
    Malfunction
    Date Received
    July 5, 2006
    Date of Event
    June 20, 2006
    Report Date
    July 5, 2006
    Manufacturer
    BIOCARE SYSTEMS, INC.
    Product Code
    ILY
    Removal / Correction Number
    CAR #102
    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 UNITED 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. ALL UNITS PASSED UL 1310'S DIRECT PLUG-IN BLADE SECURENESS TEST. IN ADDITION, 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 2 COMPLAINTS AND ALTHOUGH IT IS CONSIDERED A MISUSE APPLICATION, IT DOES REFLECT A POTENTIAL REAL WORLD SCENARIO. FOR THIS TEST, EACH UNIT WAS PLUGGED INTO A ORDINARY WALL OUTLET AND PULLED OT 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. UNITS THAT WERE SUBJECTED TO A STRAIGHT PULL FAILED WITH ONE BLADE BEING COMPLETELY REMOVED FROM THE UNIT AND THE SECOND BLADE BEING EITHER LOOSE OR HANGING OUT OF THE AC ADAPTER HOUSING. ALL UNITS SUBJECTED TO A 45 DEGREES ANGULAR PULL FAILED WITH BOTH BLADES BEING COMPLETELY REMOVED FROM THE AC ADAPTER. CONCLUSION: THIS PARTICULAR UNIT FAILED IN THE EXACT SAME WAY IN WHICH THE FIRST 2 UNITS HAD. UNIT SHOWS EVIDENCE OF BEING REMOVED FROM THE SOCKET FROM THE CORD. TESTING INDICATES THAT THE FAILURE MODE IS CAUSED BY THE APPLICATION OF FORCE IN THE TANGENTIAL DIRECTION, WHICH INDICATES THE USER DID NOT ALWAYS REMOVE THE POWER SUPPLY BY THE WALL WART, BUT WAS REMOVED FROM THE WALL BY THE CORD ONE OR MORE TIMES. (B)(4).

    Description of Event or Problem · 1

    USER OF THE DEVICE NOTED DURING A SAFETY ALERT NOTIFICATION CALL, (CALLS WERE BEING MADE BY BIOCARE EMPLOYEES BASED ON 2 OTHER COMPLAINTS, WHICH RESULTED IN A RECALL OF THE POWER SUPPLY) THAT 1 OF THE ADAPTER'S PRONGS BROKE OFF WHILE THE UNIT WAS IN THE CUSTOMER'S POSSESSION. THIS INCIDENT WAS THE ONLY POWER SUPPLY ISSUE IDENTIFIED FOR ALL CALLS MADE. THE CUSTOMER NOTICED THAT A PRONG WAS MISSING AND THAT IT HAD REMAINED IN THE WALL OUTLET. USER SAID SHE ALWAYS PULLED THE ADAPTER OUT OF THE SOCKET BY THE WALL WART AND NOT THE CORD AND WITHOUT ANY EXCESSIVE FORCE. NO INJURIES OCCURRED AS A RESULT OF THIS EVENT. THERE HAVE BEEN 2 OTHER REPORTED FAILURES OF THIS TYPE, IN BOTH CASES IT WAS CONCLUDED THAT THE POWER SUPPLY WAS PULLED FROM THE WALL BY THE CORD, AND NOT THE POWER SUPPLY HOUSING. THE RESULTING FAILURE WAS THAT THE PRONGS FROM THE POWER SUPPLY BECAME SEPARATED FROM THE HOUSING AND REMAINED IN THE SOCKET. THE POWER SUPPLY FOR THIS INCIDENT WAS VISUALLY INSPECTED AND IT WAS DETERMINED THAT THE PRONGS FROM THE POWER SUPPLY WERE DETACHED FROM THE SWAGING LOCATION. THE UNIT DISPLAYED OBVIOUS DEFORMATION OF THE PLASTIC SURROUNDING THE ENTRY POINT OF THE BLADES TO THE HOUSING, WHICH INDICATED THE UNIT WAS PULLED FROM THE SOCKET IN A TANGENTIAL DIRECTION, LIKELY BY THE CORD. REVIEW OF THE DHR DID NOT INDICATE ANY MANUFACTURING ISSUES WITH THE POWER SUPPLY.

    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