BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIELD SURGICAL LIGHT

    MDR report key: 286100 · Received July 17, 2000

    Report

    Report Number
    MW1019298
    Event Type
    Malfunction
    Date Received
    July 17, 2000
    Report Date
    June 29, 2000
    Manufacturer
    GETINGE/CASTLE, INC.
    Product Code
    KYT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNIT DOES NOT STOP CHARGING THE LEAD ACID BATTERIES WHEN FULL CHARGE IS REACHED. BATTERIES GET VERY HOT AND SWELL, WHICH RUINS THE BATTERIES AND REQUIRES THEIR REPLACEMENT. MFR'S MANUAL STATES THAT BATTERIES REQUIRE 8 HRS TO REACH FULL CHARGE BUT DOES NOT WARN THAT UNIT MUST BE UNPLUGGED. AS REPORTED BY BIOMEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIELD SURGICAL LIGHT FIELD SURGICAL LIGHT KYT GETINGE/CASTLE, INC. 2410 MB *

    Patients

    Seq Age Sex Outcome Treatment
    1 *