BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-MR1

    MDR report key: 18289363 · Received December 8, 2023

    Report

    Report Number
    3001421318-2023-10070
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    October 11, 2022
    Report Date
    August 23, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800761
    PMA / PMN Number
    K153046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG OVER 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. THE ROOT CAUSE WAS DETERMINED TO BE A USE ERROR. IN CONSEQUENCE THE DEVICE WAS SERVICED. THE DEVICE FUNCTIONED AS INTENDED DURING THE INCIDENT. THERE WAS NO REPORTED PATIENT OR USER HARM. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED. UPDATED FIELDS: B4, D1, D4, G3, G6, H2, H4.

    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. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG OVER 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. THE ROOT CAUSE WAS DETERMINED TO BE A USE ERROR. IN CONSEQUENCE THE DEVICE WAS SERVICED. THE DEVICE FUNCTIONED AS INTENDED DURING THE INCIDENT. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Description of Event or Problem · 0

    MR1 WAS BROUGHT TOO CLOSE TO THE MRI -> RED LED; DEVICE COULDN'T BE TURNED OFF.

    Description of Event or Problem · 0

    MR1 WAS BROUGHT TOO CLOSE TO THE MRI. RED LED; DEVICE COULDN'T BE TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128875 HAMILTON-MR1 HAMILTON-MR1 CBK HAMILTON MEDICAL AG 161010 07630002800761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown