BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18131301 · Received November 14, 2023

    Report

    Report Number
    3001421318-2023-11269
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    September 2, 2022
    Report Date
    November 8, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 1 YEAR 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 DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS NOT USED. THE ROOT CAUSE WAS DETERMINED TO BE THE DAMAGED BASE PLATE OF THE HUMIDIFIER CHAMBER AT THE TIME OF DELIVERY DUE TO PROBABLY FALLING ON THE FLOOR OR DURING TRANSPORTATION. IN CONSEQUENCE IT WAS RECOMMEND REPLACING THE DEFECTIVE WATER CHAMBER WITH A COMPLETE BREATHING CIRCUIT SET WITH WATER CHAMBER. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    CUSTOMER REPORTS:- THERE HAVE BEEN 5 FAILURES IN TOTAL (MHRA REFERENCE 2022/009/002/501/008) THE AFFECTED UNITS LEAK WATER ONTO THE FLOOR. THESE UNITS ARE SHOWING THIS DAMAGE STRAIGHT OUT OF THE SHIPPING CONTAINER. PLEASE SEE ATTACHED PHOTOS, SUSPECT EITHER IMPACT DAMAGE OR GLUE OR DEFECTIVE ULTRASONIC WELDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876122 HAMILTON MEDICAL AG HAMILTON-H900 CBK HAMILTON MEDICAL AG HAMILTON-H900 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown