BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9400 STROBE LIGHT UNIT

    MDR report key: 9601350 · Received January 16, 2020

    Report

    Report Number
    MW5092318
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    September 4, 2019
    Report Date
    January 15, 2020
    Manufacturer
    PENTAX OF AMERICA, INC.
    Product Code
    EQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE 9400 STROBE LIGHT UNIT DEVELOPED CORROSION OF THE WIRE SUPPLYING ELECTRICITY TO THE XENON LIGHT BULB CAUSING THE WIRE TO LET OUT ELECTRICAL SPARKS WHEN THE XENON LIGHT BULB WAS IN USE. UNIT SN (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61634 9400 STROBE LIGHT UNIT LARYNGOSTROBOSCOPE EQL PENTAX OF AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1