BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE

    MDR report key: 15629294 · Received October 18, 2022

    Report

    Report Number
    15629294
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 20, 2022
    Report Date
    September 27, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    FEQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SETTING UP PROCEDURE ROOM FOR FIRST CASE. WATER NOT FLOWING THROUGH THE ERBEFLO CLEVER CAP TUBING. CHANGED TO ANOTHER ERBEFLO CLEVER CAP TUBING WITH NO PROBLEMS NOTED. TUBING SAVED AND GIVEN TO UNIT'S APSM. ERBEFLO REF# (B)(4) LOT# 20220269-PG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047273 ERBE PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE FEQ ERBE ELEKTROMEDIZIN GMBH 20325-240 20220269-PG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown