HAMILTON-T1
Report
- Report Number
- 3001421318-2024-01498
- Event Type
- Malfunction
- Date Received
- June 24, 2024
- Date of Event
- May 18, 2024
- Report Date
- September 25, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- 003
Narratives
HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.
HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D3, D4, G6, H2, H4, H11. FOLLOW-UP 2 - ADDITIONAL INFORMATION: THE ENTRY FIELDS B4, G6, H2, H3, H6 AND H11 HAVE BEEN UPDATED. THE VENTILATOR WENT INTO AMBIENT MODE AND ALARMED WITH TFS DURING VENTILATION OF A PATIENT. NO HARM REPORTED. THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY TO A PATIENT. THE LOG FILES CONFIRMED THE ISSUE. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A DEFECTIVE CONTROL BOARD. AFTER REPLACING THE CONTROL BOARD, THE VENTILATOR PASSED ALL TESTS, AND THE DEVICE WAS RELEASED BACK INTO USE.
THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 20 MAY 2024 IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 18 MAY 2024, WHEN PATIENT WAS PLACED ON A HAMILTON-T1 (SN (B)(6), ROUGHLY 5-10 MINUTES AFTER VENTILATION THEY WERE PRESENTED WITH 249012 ERROR CODES AND OTHER MESSAGE, THEY CLEARED ALARM MESSAGES AND KEPT PATIENT ON MACHINE WHILE RECEIVING SOME TYPE OF 'PANEL MESSAGES', A BIT AFTER THAT IT APPEARS VENT WENT INTO AMBIENT MODE. NO OTHER INFORMATION AVAILABLE. A QUESTIONNAIRE WAS SENT TO CUSTOMER TO COLLECT ADDITIONAL INFORMATION, ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.
THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 20 MAY 2024 IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON (B)(6) 2024, WHEN PATIENT WAS PLACED ON A HAMILTON-T1 (SN (B)(6)), ROUGHLY 5-10MINUTES AFTER VENTILATION THEY WERE PRESENTED WITH 249012 ERROR CODES AND OTHER MESSAGE, THEY CLEARED ALARM MESSAGES AND KEPT PATIENT ON MACHINE WHILE RECIEVING SOME TYPE OF 'PANEL MESSAGES', A BIT AFTER THAT IT APPEARS VENT WENT INTO AMBIENT MODE. NO OTHER INFORMATION AVAILABLE. A QUESTIONNAIRE WAS SENT TO CUSTOMER TO COLLECT ADDITIONAL INFORMATION. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.
THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 20 MAY 2024: IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 18 MAY 2024, WHEN PATIENT WAS PLACED ON A HAMILTON-T1 (SN (B)(6)), ROUGHLY 5-10MINUTES AFTER VENTILATION THEY WERE PRESENTED WITH 249012 ERROR CODES AND OTHER MESSAGE, THEY CLEARED ALARM MESSAGES AND KEPT PATIENT ON MACHINE WHILE RECIEVING SOME TYPE OF 'PANEL MESSAGES', A BIT AFTER THAT IT APPEARS VENT WENT INTO AMBIENT MODE. NO OTHER INFORMATION AVAILABLE. A QUESTIONNAIRE WAS SENT TO CUSTOMER TO COLLECT ADDITIONAL INFORMATION, ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1103337 | HAMILTON-T1 | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | 1610060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |