BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 20012710 · Received August 21, 2024

    Report

    Report Number
    3001421318-2024-01967
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 19, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "A STAFF MEMBER OBSERVED A MILD ELECTRIC SHOCK WITH NO LASTING EFFECT WHILE PLUGGING THE POWER CABLE OF THE PELICAN CASES INTO MAINS POWER". THE APPARENTLY DEFECTIVE PART IS THE MSP PELICASE POWER CORD STRAIGHT PLUG AND SOCKET WITH A 1.4M CORD (PN 10077541). THIS MSP PELICASE POWER CORD (PN 10077541) CONNECTS THE HAMILTON-T1 TO THE POWER PLUG FROM THE INSIDE OF THE PELI TRANSPORT CASE (PN 161164). THIS OCCURRENCE WAS NOTICED DURING SETUP PREPARATION. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NO DELAY IN TREATMENT IS REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372688 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161009 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown