MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-T1

Model Number	HAMILTON-T1
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The t1 switched off suddenly while transferring patient from icu to another ward, the patient nearly die.Patient was using the t1 from several days before to 21-oct.Time of incidence was around 12:00 noon 21-oct.According to nurses, 15 minutes after transport, the t1 suddenly switched off.Nurses checked whether battery was securely attached to t1, and also plug and unplug.Therefore in the event log it shows the battery connect and disconnect.After that they continue using, and the t1 turned off several times during transport (not only one time).
Additional Manufacturer Narrative
The complaint has been reopened and reviewed according to fda form 483 inspectional observation ems no, 2, eobs2 from the fda inspection conducted between july 17 to july 21, 2022 at the ems and bonaduz sites.A detailed investigation was performed by an expert from the technical service: no further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event similar to this issue as it will be deemed a reportable event.The allegation in this complaint was confirmed to be a complaint.With this investigation it has been confirmed that the device shut down during ventilation of a patient due to the missing battery cap.The root cause was determined to be improper maintenance.In consequence the battery cap was installed as intended.There was potential patient harm.The patient nearly died; more information was not provided.

• Brand Name: HAMILTON MEDICAL AG
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, graubuenden 7402 ; SZ 7402
• Manufacturer Contact: andre sonnenberg ; via crusch 8; bonaduz, graubuenden 7402 ; SZ 7402
• MDR Report Key: 18719953
• Report Number: 3001421318-2024-42709
• Device Sequence Number: 4342501
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Report Date (Section B): 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HAMILTON-T1
• Device Catalogue Number: 161009
• 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: 10/26/2022
• Initial Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown