BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 21229455 · Received January 24, 2025

    Report

    Report Number
    3001421318-2025-00161
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    June 6, 2024
    Report Date
    May 1, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE POWER SUPPLY UNIT. IN CONSEQUENCE THE CORRECTION TO REPLACE THE POWER UNIT RESOLVED THE ISSUE. THERE WAS NO PATIENT OR USER HARM. ADDITIONAL INFORMATION ADDED IN FOLLOW-UP #1 (B)(4). FIELD UPDATED. THE ALARM "LOSS OF EXTERNAL POWER» OCCURRED DURING TESTING. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THERE IS NO INFORMATION THAT REASONABLY SUGGEST THAT THE DEVICE HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THEREFORE, BASED ON THIS INFORMATION, THE EVENT IS ASSESSED AS NO LONGER REPORTABLE AND THE EVENT CAN BE CLOSED WITH THIS FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE POWER SUPPLY UNIT. IN CONSEQUENCE THE CORRECTION TO REPLACE THE POWER UNIT RESOLVED THE ISSUE. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "DEVICE CAME IN FOR AC POWER NOT BEING RECOGNIZED. FOUND THAT TO BE TRUE AND BATTERY WAS NOT BEING CHARGED. REPLACEMENT OF THE POWER SUPPLY RESOLVED THE ISSUE. BATTERY IS NOW BEING CHARGED AND AC POWER IS NOW BEING RECOGNIZED BY THE DEVICE. FROM: 396232: 02: 001167 TO MSP396232: 03: 001435. SERVICE SOFTWARE AND FUNCTION CHECKS ALL PASS.REPLACED POWER SUPPLY." (2) HEALTH IMPACT: NO PATIENT INVOLVMENT. DURING A TEST.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: (1) DETAILED COMPLAINT AND FAILURE DESCRIPTION: "DEVICE CAME IN FOR AC POWER NOT BEING RECOGNIZED. FOUND THAT TO BE TRUE AND BATTERY WAS NOT BEING CHARGED. REPLACEMENT OF THE POWER SUPPLY RESOLVED THE ISSUE. BATTERY IS NOW BEING CHARGED AND AC POWER IS NOW BEING RECOGNIZED BY THE DEVICE. FROM: 396232: 02: 001167 TO MSP396232: 03: 001435. SERVICE SOFTWARE AND FUNCTION CHECKS ALL PASS.REPLACED POWER SUPPLY." (2) HEALTH IMPACT: NO PATIENT INVOLVMENT. DURING A TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722710 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown