BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM SURGERY LIGHT CONTROL

    MDR report key: 21380 · Received April 21, 1995

    Report

    Report Number
    MW1005694
    Event Type
    Malfunction
    Date Received
    April 21, 1995
    Date of Event
    March 9, 1995
    Report Date
    March 17, 1995
    Manufacturer
    AMERICAN STERILIZER CO.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE IN THE HEART ROOM IN THE OPERATING SUITE, THE NUMBER TWO SURGERY LIGHT FAILED. WHEN THE MAINTENANCE TECHNICIAN PULLED FUSE F2, THE NUMBER ONE SURGERY LIGHT WENT OFF. INSPECTION AFTER THE PROCEDURE, SHOWED WIRES 33/42 WERE ON F2 INSTEAD OF F1, AND 68/69 WERE ON F1 INSTEAD OF F2. INSPECTION OF OTHER SURGERY LIGHTS WHICH WERE MADE BY THE MFR IN THE OPERATING SUITE, SHOWED 7 OF THE 10 CONTROLS TO BE MISWIRED. MFR'S TECHNICAL SUPPORT WAS NOTIFIED 3/10/95 WHEN 3 OF 5 CONTROLS WERE FOUND TO BE MISWIRED, AND AGAIN ON 3/13/95 AT THE FINAL COUNT OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM SURGERY LIGHT CONTROL SURGERY LIGHT CONTROLS FSY AMERICAN STERILIZER CO. QL00-001-1 8928992 014 & 8928992 002

    Patients

    Seq Age Sex Outcome Treatment
    1 *