BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17893212 · Received October 9, 2023

    Report

    Report Number
    3001421318-2023-30113
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    December 19, 2019
    Report Date
    October 7, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 (B)(6), 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 DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS NOT IN USE. THE ROOT CAUSE WAS DETERMINED TO BE DEFECTIVE FLOATER DUE TO AGED CHAMBERS. IN CONSEQUENCE THE BREATHING SET WITH CHAMBER WAS REPLACED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    H900 HUMIDIFIER WAS SET IT UP ON A C1 FOR AN IMPENDING DELIVERY OF A BABY THE CIRCUIT AND CHAMBER WORKED FINE PER OP, WHEN THEY WENT TO PUT THE BABY ON THE C1 THE VENT ALARMS WERE STATED OBSTRUCTION. IT WAS DISCOVERED THAT THERE WAS A LOT OF WATER IN BOTH SIDES OF CIRCUIT. THE HUMIDIFIER CHAMBER WAS COMPLETELY FULL- AND THE C1 AND H900 WERE CHANGED OUT. CIRCUIT 260185/04 CHAMBER DATE 18114 LOT # 1053169 AFTER WE STABILIZED THE BABY- I WENT TO LOOK AT THE HEATER AND THERE WAS WATER ALL OVER THE FLOOR- AND DRIPPING FROM THE C1. THERE ABSOLUTELY IS WATER IN THE VENT- THE BIOMED PERSON WAS UP HERE AND TOOK IT DOWN TO THEIR OFFICE. I AM SAVING THE CIRCUIT AND CHAMBER FULL OF WATER- BUT OF COURSE I AM ASKING YOU HOW THIS COULD HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121841 HAMILTON MEDICAL AG HAMILTON-H900 CBK HAMILTON MEDICAL AG HAMILTON-H900 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown