BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16023721 · Received December 21, 2022

    Report

    Report Number
    3001421318-2022-00094
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    December 14, 2022
    Report Date
    March 31, 2022
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG HAS NOT RECEIVED THE DEVICE FOR INVESTIGATION SO FAR. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INCIDENT WAS REPORTED TO THE MANUFACTURER "PHILIPS AG" FOR INVESTIGATION. ACCORDING TO THEIR INVESTIGATION, THIS IS THE FIRST COMPLAINT OF THIS KIND THAT WAS RECEIVED SO FAR. THE DEVICE HISTORY RECORD SHOWED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. FURTHERMORE, THE FIXATION WAS REVIEWED AND IS FOUND TO BE SUFFICIENT. ON THE BASIS OF THE INFORMATION WE HAVE COLLECTED, WE ASSUME THAT THERE IS AN ISOLATED CASE IN THE HOSPITAL IN SWITZERLAND IN WHICH UNFAVORABLE INFLUENCES HAVE ACCUMULATED THAT WE HAVE NOT BEEN ABLE TO DETERMINE, REPRODUCE AND EVALUATE IN A QUALIFIED MANNER TO DATE. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: UNIVERSAL BED MOUNT 161148 ALMOST FELL ON A PATIENT, SHE FIXED THE EQUIPMENT. THE C1 IS MOUNTED ABOVE THE HEAD OF THE PATIENT AND THAT WOULD BE A REAL PITY IF IT FALLS ON THE HEAD. NO PATIENT HARM OCCURRED AS VENTILATOR WAS NEVER ON PATIENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: UNIVERSAL BED MOUNT 161148 ALMOST FELL ON A PATIENT, SHE FIXED THE EQUIPMENT. THE C1 IS MOUNTED ABOVE THE HEAD OF THE PATIENT AND THAT WOULD BE A REAL PITY IF IT FALLS ON THE HEAD. NO PATIENT HARM OCCURRED AS VENTILATOR WAS NEVER ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476266 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown