BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OP PLUS, MEDICAL EXAMINATION LIGHT

    MDR report key: 5588105 · Received April 20, 2016

    Report

    Report Number
    3009542956-2016-00002
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    February 8, 2016
    Report Date
    February 22, 2016
    Manufacturer
    PHILIPS BURTON
    Product Code
    KZF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS BURTON RECEIVED A CUSTOMER'S COMPLAINT REGARDING OP PLUS LIGHT BROKE OFF ON (B)(6) 2016. DURING A PROCEDURE THE MEDICAL ASSISTANT WAS MOVING THE LIGHT, IT BROKE OFF AT THE FIRST SWIVEL SECTION, AND THEN FELL DOWN. CONSEQUENTLY THE LIGHT DID NOT IMPACT ANY PERSON, AND THERE WERE NO INJURIES. CAPA HAS BEEN OPENED IN PHILIPS BURTON QUALITY SYSTEM TO DOCUMENT THE INCIDENT AND ASSURE ACCURATE AND TIMELY SUBMITTING OF MDRS. NOTE: THE LIGHT WAS MANUFACTURED IN 1995 AND IS WELL BEYOND ITS WARRANTY PERIOD AND USABLE LIFE. DEVICE IS OVER 20 YEARS OLD.

    Description of Event or Problem · 1

    ON (B)(4) 2016 PHILIPS BURTON RECEIVED A COMPLAINT FROM (B)(6) REGARDING OP PLUS LIGHT BROKE OFF. THE COMPLAINT STATE'S: "WE HAD AN INCIDENT ON (B)(6) WITH A CEILING MOUNTED BURTON OUTPATIENT II LIGHT. IN THE MIDDLE OF A PROCEDURE, THE LIGHT BROKE OFF. FORTUNATELY, THE PATIENT WAS ONLY SHAKEN AND NOT HURT. IT COULD HAVE SHUT DOWN THE ROOM, BUT WE HAD A DAY FULL OF PROCEDURES, SO WE HAD TO IMPROVISE. SINCE WE COULD NOT MOVE THE PROCEDURE CHAIR, WE CUT THE LAMP WIRES AND REMOVED THE DANGLING LIGHT. IN ITS PLACE, WE USED A PORTABLE LIGHT (ONE OF YOURS TOO). I HAVE ATTACHED PHOTOS OF THE BREAK. THE METAL LITERALLY TORE APART. GRANTED THESE LIGHTS ARE OLD AND OUT OF WARRANTY, BUT IS THIS NORMAL? THE BROKEN LIGHT IS MODEL 0102540, SERIAL NUMBER (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247584 OP PLUS, MEDICAL EXAMINATION LIGHT OPL PLUS 0102540 KZF PHILIPS BURTON 0102540 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other