BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18130066 · Received November 14, 2023

    Report

    Report Number
    3001421318-2023-21620
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    June 28, 2021
    Report Date
    November 8, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG ALMOST 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. 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 PRODUCT (FLOW SENSOR WITH PRE-ASSEMBLED TUBES) FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED WITH A PATIENT. THE ROOT CAUSE WAS DETERMINED TO BE AN ASSEMBLY ISSUE DURING THE MANUFACTURING. IN CONSEQUENCE PRODUCTS WERE REPLACED AND THERE WAS A CHANGE IN THE QUALITY CONTROL DURING THE MANUFACTURING PROCESS. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Description of Event or Problem · 0

    FLOW SENSOR TUBES ON THE 260167 COAXIAL CIRCUIT SET WERE PLACED ON BACKWARDS WHEN REMOVED FROM THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203476 HAMILTON MEDICAL AG FLOW SENSOR SINGLE USE CBK HAMILTON MEDICAL AG FLOW SENSOR SINGLE USE 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown