BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16672298 · Received April 4, 2023

    Report

    Report Number
    3001421318-2023-01193
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    August 24, 2022
    Report Date
    April 4, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE REPORT IS (B)(4).

    Description of Event or Problem · 0

    THE CALL FROM (B)(6) BIOMEDICAL DEPARTMENT VENTILATOR SHOWED A TECHNICAL FAULT. THE VENTILATOR WAS NON-FUNCTIONAL FROM 24.8.2022 AND LEBENTEC MEDICAL SYSTEMS AND GULMOHAR HEALTH CARE NOT RESPONDING THEM PROPERLY TO FIX THE PROBLEM. ON THE TELEPHONE GUIDED THE BIOMEDICAL ENGINEER TO CHECK THE FOLLOWING. 1. CENTRAL O2 INLET PRESSURE WAS OK. 2. HPO INLET FILTER WAS CLEAR. 3. CHECKED O2 INPUT IT WAS OK, NEEDS TO CHECK O2 MIXER ASSEMBLY. ISSUE POTENTIALLY RELATED TO DEFECTIVE O2 PROPORTIONAL VALVE, MIXER ASSEMBLY OR LEAK IN LPO/HPO INLE. ONSITE CORRECTION: CHECK THE LPO/HPO INLET FOR LEAKS AS THIS COULD LEAD TO 231008 EVEN THOUGH THE O2 VALVE IS WORKING PROPERLY. IF HPO IS USED, THEN MAKE SURE NO LPO CONNECTOR IS CONNECTED TO THE LPO INLET. AND CHECK THE O2 MIXER FOR PROPER FUNCTION WITH SERVICE SOFTWARE, PNEUMATICS 2,O2 INPUT (PAGE 2112), AND SYSTEM TEST, O2 MIXER (PAGE 2203). AND INSTALL LATEST SOFTWARE VERSION. AND REPLACE THE O2 MIXER ASSEMBLY. ISSUE OCCURRED DURING PRE-OP CHECK. NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT AND OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060618 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown