BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENLON ANESTHESIA DELIVERY UNIT

    MDR report key: 11292889 · Received February 5, 2021

    Report

    Report Number
    MW5099263
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    November 10, 2020
    Report Date
    February 3, 2021
    Manufacturer
    PENLON, LTD.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING A PROCEDURE AND THE SCREEN ON THE PENLON MACHINE WAS NOT WORKING. IT KEPT FREEZING AND THE TOUCH SCREEN AND THE CONTROL KNOB COULD NOT SELECT ANYTHING, BUT THE ANIMATIONS ON THE SCREEN WERE STILL ACTIVE. THE MACHINE WAS SWITCHED OUT AND SURGERY PROCEEDED WITH NO ADVERSE OUTCOME. BIOMED CONTACTED PENLON AND AVANTE, MACHINE WAS TESTED BUT PROBLEM COULD NOT BE DUPLICATED. AVANTE RECOMMENDED REPLACING SCREEN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186251 PENLON ANESTHESIA DELIVERY UNIT GAS-MACHINE, ANESTHESIA BSZ PENLON, LTD. PRIMA460

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other