BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16407739 · Received February 21, 2023

    Report

    Report Number
    3001421318-2023-00251
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    June 2, 2020
    Report Date
    November 16, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Adverse Event
    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.  REPORTED BY USER WITHIN US. UF/IMPORTER REPORT #: 2937708-2020-82545. 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. 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 COULD NOT BE CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE HUMIDIFIER WAS USED FOR TREATMENT. THE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES ARE TEMPORARY SENSOR FAILURE OR HEATING OF STATIONARY AIR BY THE HUMIDIFIER FOLLOWING A SUDDEN FLOW. IN CONSEQUENCE THE PATIENT WAS TAKEN FROM THE DEVICE. THE DEVICE AND ITS CONSUMABLES WERE SENT TO HAMILTON MEDICAL FOR INVESTIGATION AND THE ISSUE COULD NOT BE REPLICATED. THERE WAS PATIENT HARM DUE TO SECOND-DEGREE BURNS.

    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.  REPORTED BY USER WITHIN US. UF/IMPORTER REPORT #: 2937708-2020-82545. USER REPORTED INFANT WAS PLACED ON DEVICE AND "APPROXIMATELY" FIVE MINUTES LATER THE PATIENT WAS FOUND CRYING. IT WAS REPORTED THAT THE DEVICE'S TEMP DISPLAY SHOWED AN INITIAL READING OF 30.9 AND WAS FOUND TO BE 54.8 WHEN REMOVED. HAMILTON MEDICAL AG PERFORMED A HARDWARE ANALYSIS OF THE HAMILTON-H900 AND CONCLUDED THAT THE EVENT WAS NOT REPRODUCIBLE. A ROOT CAUSE COULD THEREFORE NOT BE IDENTIFIED. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT COULD CAUSE SERIOUS INJURY OR DEATH IF IT WAS TO REOCCUR.

    Description of Event or Problem · 0

    CUSTOMER STATES TEMPERATURE INCREASED TO 50 C IN NIV MODE. ALSO CUSTOMER STATES LEFT SIDE TUBE FAILURE ON A DUAL LIMB CIRCUIT PART# 260185. POTENTIAL DISCOMFORT IN THE BABIES NARES WITH SWELLING. UNABLE TO REPLICATE THIS AFTER REMOVING THE HUMIDIFIER AND CIRCUIT.

    Description of Event or Problem · 0

    CUSTOMER STATES TEMPERATURE INCREASED TO 50 C IN NIV MODE. ALSO CUSTOMER STATES LEFT SIDE TUBE FAILURE ON A DUAL LIMB CIRCUIT PART# 260185. POTENTIAL DISCOMFORT IN THE BABIES NARES WITH SWELLING. UNABLE TO REPLICATE THIS AFTER REMOVING THE HUMIDIFIER AND CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926605 HAMILTON MEDICAL AG HAMILTON-H900 CBK HAMILTON MEDICAL AG HAMILTON-H900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R