BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE

    MDR report key: 18255885 · Received December 4, 2023

    Report

    Report Number
    18255885
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 3, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ERBE MACHINE ALARMED DEFECTED CARTRIDGE/PUMP. IT WAS CHANGED OUT. ABOUT ANOTHER 30 MIN INTO PROCEDURE ALARMED AGAIN. SERVICE REP CONTACTED. THE THIRD CARTRIDGE SET LASTED TILL END OF CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632684 ERBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ERBE ELEKTROMEDIZIN GMBH 20150-300 W0394286

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other