MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: this event was reported to hamilton medical ag as, ventilator device alarmed.This occurrence was noticed when the ventilator device was in standby mode and has not been further explained nor clarified.A continuous alarm was observable both visually (error code) and through hearing.Te231008 (o2 valve leak).The device log files (service log, error log, event log) were provided to hamilton.This malfunctioning was reproducible.There is no patient involvement reported.There is no need for any medical intervention reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).The investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).The investigation is ongoing.A detailed investigation was performed by an expert from the technical service: this issue is deemed a reportable event since the malfunction 'technical event:231008' due to leaky o2 valve can lead to a delay in the therapy since the ventilator cannot be used.A new ventilator needs to be prepared.The root cause of the ventilator to alarm with "technical event:231008" was a malfunction of the o2 mixer valve causing a leak.(mechanically jammed due storage of the device for a long period before usage).Within this investigation it has been confirmed that the device failed to meet its specifications at the time of the event while the ventilator was prepared to be used for treatment or diagnosis (preop check).There was no patient or user harm.The allegation in this complaint was confirmed to be a complaint.This device was produced before 2015.No udi available.
Event or Problem Description
The following was reported to hamilton medical ag: - this event was reported to hamilton medical ag as, ventilator device alarmed.- this occurrence was noticed when the ventilator device was in standby mode and has not been further explained nor clarified.- a continuous alarm was observable both visually (error code) and through hearing.Te231008 (o2 valve leak).- the device log files (service log, error log, event log) were provided to hamilton.- this malfunctioning was reproducible.- there is no patient involvement reported.- there is no need for any medical intervention reported.- neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is ongoing.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, ; SZ
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18922633
• Report Number: 3001421318-2024-00645
• Device Sequence Number: 20709138
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 161006
• Device Catalogue Number: 161006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 08/30/2024
• Date Device Manufactured: 03/31/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown