BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM II LED SURGICAL LIGHT

    MDR report key: 2467607 · Received February 17, 2012

    Report

    Report Number
    2031963-2012-00014
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 23, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE, NO PT DATA EXISTS. THE WALL-MOUNTED POWER SUPPLY BOX THAT WAS REPLACED IS IN THE PROCESS OF BEING RETURNED TO THE MFR FOR FURTHER EVAL. THE SERIAL NUMBER AND MFG DATE IS UNK AT THE TIME OF THIS REPORT. EVAL SUMMARY: A FIELD SERVICE TECHNICIAN EVALUATED THE DEVICE IN THE FIELD AND COULD NOT REPLICATE THE ISSUE. THE SURGICAL LIGHTS TURNED ON WHEN THE FIELD SERVICE TECH POWERED THEM UP. ALTHOUGH NO FAILURE COULD BE DETECTED, THE FIELD SERVICE TECHNICIAN REPLACED THE POWER SUPPLY BOX FOR THE CUSTOMER. THE POWER SUPPLY BOX IS BEING RETURNED TO THE MFR FOR FURTHER EVAL. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4): THE CUSTOMER REPORTED THAT BOTH LED SURGICAL LIGHTS IN THE OPERATING ROOM ARE UNABLE TO TURN ON. THERE WAS NO PT INVOLVEMENT REPORTED AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISUM II LED SURGICAL LIGHT FSY STRYKER COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1