BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON-T1

    MDR report key: 16492162 · Received March 6, 2023

    Report

    Report Number
    0002937708-2023-00004
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 6, 2023
    Manufacturer
    HAMILTON MEDCIAL AG
    Product Code
    CBK
    UDI-DI
    07630002813532
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER CALLED IN ON (B)(6) FOR A HAMILTON T1 SN (B)(4) RENO RGA 23612RB WAS ISSUED. COMPLAINT WAS "DURING USE THE POWER CORD BECAME EXTREMELY "HOT" AND THE RT STAFF SMELLED SMOKE. ASSESSMENT AND REPAIR REQUESTED. BREIFLY TURNED ON UNIT VIA BATTERIES AND POWER CORD. COULD NOT REPLICATE SYMPOMS DESCRIBED. UNIT POWER CORD DID COME IN EXTREMELY 'BURNT, HOT' AND EVIDENCE OF THERE BEING HEAT/FIRE DAMAGE. ATTEMPTING TO TOUCH BASE WITH TECH WHO TOOK RGA FROM CUSTOMER, ALSO WILL ASK CUSTOMER THE STANDARD QUESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716167 HAMILTON-T1 HAMTILON-T1 CBK HAMILTON MEDCIAL AG HAMILTON-T1 07630002813532

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other