BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, VISUM LED POWER SUPPLY BOX L1 AND L2

    MDR report key: 2182244 · Received July 12, 2011

    Report

    Report Number
    2031963-2011-00067
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA AVAILABLE. THERE IS NO EXP DATE FOR THIS PRODUCT. THE SERIAL NUMBER WAS UNK AT THE TIME OF THIS REPORT. DUE TO NO IDENTIFIED SERIAL NUMBER, THERE IS NO DATE OF MANUFACTURE FOR THIS PRODUCT AT THIS TIME. THE OCCUPATION OF THE INITIAL REPORTER WAS UNK AT THE TIME OF THIS REPORT. EVAL SUMMARY: IT WAS REPORTED FROM THE CUSTOMER THAT IN OPERATING ROOM 2, THE LED LIGHT #2, THE REAR-END CAP AT THE ELBOW FELL OFF. THE COVER DID NOT FALL IN THE STERILE FIELD AND DID NOT HIT ANYBODY IN THE OPERATING ROOM. HOWEVER, IF THE COVER HAD FALLEN ONTO/INTO A PT, OR HIT SOMEBODY IN OPERATING ROOM, OR HAD FALLEN IN STERILE FIELD, A SERIOUS/SEVERE ADVERSE HEALTH EVENT COULD HAVE OCCURRED. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ASSOCIATED WITH THIS NONCONFORMANCE. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED FROM THE CUSTOMER THAT IN OPERATING ROOM 2, THE LED LIGHT #2, THE REAR-END CAP AT THE ELBOW FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKG, VISUM LED POWER SUPPLY BOX L1 AND L2 FSY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK