BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-MR1

    MDR report key: 19077578 · Received April 10, 2024

    Report

    Report Number
    3001421318-2024-00882
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    January 25, 2024
    Report Date
    September 10, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800761
    PMA / PMN Number
    K153046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4). HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: VENT SHUT DOWN AFTER MRI SCAN WHEN LEAVING OUTSIDE OF ROOM - LOG SHOWS TF 485001, TF 4431001 TF446029 AND CHECK TESLASPY YELLOW ALARM, THIS IS SECOND TIME DEVICE DID THIS WITH SAME TF ERRORS - FIRST TIME (B)(6) 2023 COMPLETED FULL PM AND VOLTAGE CHECKS (ALL FOUND WITHIN LIMITS NONE WERE FOUND NEAR HIGH OR LOW LIMITS. AFTER THE FIRST-TIME DEVICE RETURNED. SECOND TIME DEVICE IN BIOMED FOR DURATION - CALLED AND FOLLOWED TECHNICAL ADVICE AND ORDERED NEW CONTROL BOARD PART ORDER 2 /27/24. PT MANUALLY BAGGED UNTIL CURCUIT MOVED TO SECOND NEARBY VENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: VENT SHUT DOWN AFTER MRI SCAN WHEN LEAVING OUTSIDE OF ROOM - LOG SHOWS TF 485001, TF 4431001 TF446029 AND CHECK TESLASPY YELLOW ALARM, THIS IS SECOND TIME DEVICE DID THIS WITH SAME TF ERRORS - FIRST TIME ON (B)(6) 2023 COMPLETED FULL PM AND VOLTAGE CHECKS ( ALL FOUND WITHIN LIMITS NONE WERE FOUND NEAR HIGH OR LOW LIMITS. AFTER THE FIRST-TIME DEVICE RETURNED. SECOND TIME DEVICE IN BIOMED FOR DURATION - CALLED AND FOLLOWED TECHNICAL ADVICE AND ORDERED NEW CONTROL BOARD PART ORDER (B)(6) 2024. PT MANUALLY BAGGED UNTIL CIRCUIT MOVED TO SECOND NEARBY VENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413421 HAMILTON-MR1 HAMILTON-MR1 CBK HAMILTON MEDICAL AG 161010 07630002800761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown