BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17403736 · Received July 27, 2023

    Report

    Report Number
    3001421318-2023-13875
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    April 23, 2022
    Report Date
    July 24, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 NO, 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: 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 USED. THE ROOT CAUSE WAS DETERMINED TO BE A MISPLACED OR DEFECTIVE EXPIRATORY MEMBRANE. IN CONSEQUENCE (CORRECTION) THE EXPIRATORY VALVE WAS REPLACED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    BIO-MED SAID THAT DURING A PATIENT VENTILATION THE VENT HAD A CONTINUOUS ALARMS DISCONNECT ON PATIENT SIDE ALARM AND DISCONNECT ON VENTILATOR SIDE ALARM. ALARMS WERE ABLE TO REPLICATE BY HAMILTON MEDICAL INC TECHNICIAN DEVICE'S FILES WILL BE EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662679 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown