BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 18309698 · Received December 12, 2023

    Report

    Report Number
    3001421318-2023-04143
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 10, 2023
    Report Date
    July 30, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WERE UPDATED WITH FULL UDI INFORMATION AS REQUESTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HOSPITAL STAFF COMPLAINED THAT TECHNICAL EVENT:233004 (AUTOZERO ERROR QAW/PAW) AND TECHNICAL EVENT:233003 OCCURRED AGAIN WHILE USING THIS C1 WITH NCPAP. HE THEREFORE DISCONTINUED THE USE OF THIS C1 AND REPLACED IT WITH ANOTHER VENTILATOR. NO PATIENT HARM OR CONSEQUENCES.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HOSPITAL STAFF COMPLAINED THAT TECHNICAL EVENT: 233004 (AUTOZERO ERROR QAW/PAW) AND TECHNICAL EVENT: 233003 OCCURRED AGAIN WHILE USING THIS C1 WITH NCPAP. HE THEREFORE DISCONTINUED THE USE OF THIS C1 AND REPLACED IT WITH ANOTHER VENTILATOR. NO PATIENT HARM OR CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777886 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown