MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161001
Medical Device Problem Codes	Failure to Run on Battery (1466); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is: cer (b)(4).
Event or Problem Description
The following was reported to hamilton medical ag: ventilation of a patient in the rega jet.When the patient was transferred, the t1 switched off without anyone having to do anything.See movie 1 patient was ventilated manually.When the crew returned, the t1 alerted with a white screen and active ventilation.The device was very warm.User wanted to switch off the t1, but did not know that he had to press the switch for 30 seconds.The respi was then left with a battery.According to the user, it started up again automatically after approx.1 hour.No health consequences or impact.
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).A detailed investigation was performed by an expert from the technical service: the allegation in this complaint was confirmed to be a complaint.The issue is not likely to be serious to public health but has potential to cause serious injury or death, if it were to recur during the use with a patient.The operator intervened and the patient needed to be ventilated manually.Therefore, the event has been deemed to be a potentially reportable event.There was no patient, user or third-party harm reported.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event while the ventilator in use.The root cause was determined to be a defective battery which was replaced.After the replacement of the component no further issues were detected.A capa must not be initated as only 2 defective devices are acceptable considering the high number of battery implemented in the devices of the product family (hamilton-c1, t1, mr1).Nevertheless, the failures of devices in the market are monitored constantly and if the failure rate was to increase a capa will be considered.Note: this device was produced on dec 3rd 2014.No udi available.
Event or Problem Description
The following was reported to hamilton medical ag: ventilation of a patient in the rega jet.When the patient was transferred, the t1 switched off without anyone having to do anything.Patient was ventilated manually.When the crew returned, the t1 alerted with a white screen and active ventilation.The device was very warm.User wanted to switch off the t1, but did not know that he had to press the switch for 30 seconds.The respi was then left with a battery.According to the user, it started up again automatically after approx.1 hour.No health consequences or impact.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: christof mueller ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 19102622
• Report Number: 3001421318-2024-00908
• Device Sequence Number: 17994134
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 161001
• Device Catalogue Number: 161001
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/13/2024
• Supplement Report FDA Received Date: 08/23/2024
• Date Device Manufactured: 12/03/2014
• 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