BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18844221 · Received March 6, 2024

    Report

    Report Number
    3001421318-2024-00519
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 21, 2024
    Report Date
    January 5, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS PREPARED FOR TREATMENT. BASED ON THE INFORMATION FOUND, THE ROOT CAUSE AND THE CORRECTION COULD NOT BE DETERMINED. THE CUSTOMER DID NOT PROVIDE SUFFICIENT INFORMATION. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING START UP THE TF 232056 (PLAUSIBILITY BETWEEN PAMBIENT AND PFILTER FAILED) OCCURS AND SELFTEST FAILS. NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING START UP THE TF 232056 (PLAUSIBILITY BETWEEN PAMBIENT AND PFILTER FAILED) OCCURS AND SELFTEST FAILS. NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING START UP THE TF 232056 (PLAUSIBILITY BETWEEN PAMBIENT AND PFILTER FAILED) OCCURS AND SELFTEST FAILS. NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119383 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown