BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16584069 · Received March 21, 2023

    Report

    Report Number
    3001421318-2023-00796
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    March 7, 2023
    Report Date
    April 9, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813549
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE AND WAS DEEMED NON-REPORTABLE. HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG (GOOGLE TRANSLATED FROM GERMAN): THE T1 MIL WAS PREPARED FOR DELIVERY FOR A CUSTOMER. DURING THE INITIAL TEST IN THE TECHNICAL ROOM AT (B)(6), THE T1 FAILED THE AIR ENTRY TEST AND FAILED THE SELF-TEST WITH TECHNICAL EVENT:232056. THE DEVICE HAS NEVER BEEN ON A PATIENT. THE TEST AIR ENTRY WAS TESTED WITH THE REAR PANEL INSTALLED WHICH INCLUDES THE ABC FILTER CONNECTOR. THE ABC FILTER WAS NOT INSTALLED. AT THE FIRST TEST POINT, THE T1 PASSED. AT THE SECOND TEST POINT, THE DEVICE FAILED THE TEST. THE T1 NEVER CAME TO THE SEALING TEST WITH THE FOIL. NO PATIENT INVOLVEMENT AS IT OCCURRED OUT OF THE BOX TESTING AT THE SALES PARTNER COMPANY.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG (GOOGLE TRANSLATED FROM GERMAN): THE T1 MIL WAS PREPARED FOR DELIVERY FOR A CUSTOMER. DURING THE INITIAL TEST IN THE TECHNICAL ROOM AT HEINEN LÖWENSTEIN, THE T1 FAILED THE AIR ENTRY TEST AND FAILED THE SELF-TEST WITH TECHNICAL EVENT:232056. THE DEVICE HAS NEVER BEEN ON A PATIENT. THE TEST AIR ENTRY WAS TESTED WITH THE REAR PANEL INSTALLED WHICH INCLUDES THE ABC FILTER CONNECTOR. THE ABC FILTER WAS NOT INSTALLED. AT THE FIRST TEST POINT, THE T1 PASSED. AT THE SECOND TEST POINT, THE DEVICE FAILED THE TEST. THE T1 NEVER CAME TO THE SEALING TEST WITH THE FOIL. NO PATIENT INVOLVEMENT AS IT OCCURRED OUT OF THE BOX TESTING AT THE SALES PARTNER COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356349 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 07630002813549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown