HAMILTON-T1
Report
- Report Number
- 3001421318-2024-02193
- Event Type
- Death
- Date Received
- September 12, 2024
- Date of Event
- August 22, 2024
- Report Date
- November 18, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002806091
- PMA / PMN Number
- K181216
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). INVESTIGATION IS ONGOING. DUE TO THE MISSING SERIAL NUMBER, UDI INFORMATION IN SECTION D4 COULD NOT BE COMPLETED. THE IMPORTER REPORT NUMBER OF OUR IMPORTER HAMILTON MEDICAL INC IS 3016723884-2024-00013. FOLLOW-UP NR. 1 INFORMATION: ADDITIONAL INFORMATION: FIELD H10 - ENTERING OF IMPORTER MEDICAL DEVICE REPORT (MDR) NUMBER: 3016723884-2024-00013.
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(6) INVESTIGATION IS ONGOING. DUE TO THE MISSING SERIAL NUMBER, UDI INFORMATION IN SECTION D4 COULD NOT BE COMPLETED. THE IMPORTER REPORT NUMBER OF OUR IMPORTER HAMILTON MEDICAL INC IS (B)(4).
THIS ADVERSE EVENT IS BEING REPORTED IN ACCORDANCE WITH 21 CFR PART 803 DUE TO THE RESULTING PATIENT DEATH. BASED ON THE INVESTIGATION CONDUCTED BY HAMILTON MEDICAL AG, THE INCIDENT OCCURRED DURING CLINICAL USE OUTSIDE THE APPROVED DEVICE, WHICH IS DESCRIBED IN THE DEVICE'S INSTRUCTIONS FOR USE AND HAS BEEN VALIDATED BY THE MANUFACTURER. SPECIFICALLY, THE HAMILTON-T1 VENTILATOR WAS OPERATED IN A PULL-THROUGH CONFIGURATION WITH A UPAC VAPORIZER AND AN NBC-COMPATIBLE HEPA FILTER. THIS CONFIGURATION IS NOT DESCRIBED OR SUPPORTED IN ANY DOCUMENTATION FROM HAMILTON MEDICAL AG AND WAS NOT CONSIDERED IN THE DEVICE'S RISK ANALYSIS. IT IS LIKELY THAT THE COMBINATION OF INCREASED FLOW DEMAND AND ADDED RESISTANCE CONTRIBUTED TO UNCONTROLLED PRESSURE DELIVERY. THEREFORE, THE EVENT IS NOT CONSIDERED TO BE CAUSED BY A DEVICE DEFICIENCY.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: A. SUMMATION OF THE EVENT: AN ANESTHESIA PROVIDER IN A DEPLOYED SETTING WAS USING THE HAMILTON-T1 VENTILATOR WITH THE UPAC VAPORIZER IN A PULL-THROUGH CONFIGURATION. AT CASE COMPLETION, THE PROVIDER INCREASED THE DELIVERED OXYGEN (HIGH PRESSURE PORT ATTACHED TO A REGULATOR-LIMITED H-CYLINDER) TO 100%. IN QUICK SUCCESSION, THE VENTILATOR INCREASED AIR FLOW TO >100 LPM, AND DELIVERED UNCONTROLLED HIGH PRESSURE TO THE PATIENT VIA THE ENDOTRACHEAL TUBE IN SITU. THIS WAS FOLLOWED BY A COMPLETE FAILURE OF THE HAMILTON-T1 VENTILATOR AND UNREGULATED VENTILATOR SHUT-DOWN. DURING TEST LUNG EXPERIMENTS PEAK AIRWAY PRESSURES AS HIGH AS 80MMHG WERE NOTED IMMEDIATELY PRECEDING THE T1 FAILURE. B. CAUSATIVE ELEMENTS: THE HAMILTON-T1 USED WAS EQUIPPED WITH THE NBC-COMPATIBLE HEPA AIR FILTER (HAMILTON PART NUMBER 161705), INTENDED TO BE USED IN CONTAMINATED ENVIRONMENTS IN CONCERT WITH A STANDARD NATO NBC CARTRIDGE FILTER ATTACHED TO THE AIR INLET ON THE BACK OF THE HAMILTON-T1 (NBC FILTER ADAPTER INSTRUCTION FOR USE, REF 161747, HAMILTON MEDICAL). THIS HEPA FILTER IMPROVES REMOVAL OF NBC CONTAMINATES FROM THE TRANSPORT VENTILATOR'S DELIVERED BREATHS TO THE PATIENT. LIKELY, DUE TO THIS INCREASED FILTRATION (RESISTANCE TO AIR FLOW) WHEN COUPLED WITH THE INCREASED DEMAND OF THE VENTILATOR ATTEMPTING TO DELIVER THE SET 100% OXYGEN CONCENTRATION, AND ON SEPTEMBER 10TH, 2024, HAMILTON MEDICAL AG ADDITIONALLY RECEIVED THE INFORMATION THAT THE INCIDENT RESULTED IN PATIENT DEATH.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: A. SUMMATION OF THE EVENT: AN ANESTHESIA PROVIDER IN A DEPLOYED SETTING WAS USING THE HAMILTON-T1 VENTILATOR WITH THE UPAC VAPORIZER IN A PULL-THROUGH CONFIGURATION. AT CASE COMPLETION, THE PROVIDER INCREASED THE DELIVERED OXYGEN (HIGH PRESSURE PORT ATTACHED TO A REGULATOR-LIMITED H-CYLINDER) TO 100%. IN QUICK SUCCESSION, THE VENTILATOR INCREASED AIR FLOW TO >100 LPM, AND DELIVERED UNCONTROLLED HIGH PRESSURE TO THE PATIENT VIA THE ENDOTRACHEAL TUBE IN SITU. THIS WAS FOLLOWED BY A COMPLETE FAILURE OF THE HAMILTON-T1 VENTILATOR AND UNREGULATED VENTILATOR SHUT-DOWN. DURING TEST LUNG EXPERIMENTS PEAK AIRWAY PRESSURES AS HIGH AS 80MMHG WERE NOTED IMMEDIATELY PRECEDING THE T1 FAILURE. B. CAUSATIVE ELEMENTS: THE HAMILTON-T1 USED WAS EQUIPPED WITH THE NBC-COMPATIBLE HEPA AIR FILTER (HAMILTON PART NUMBER 161705), INTENDED TO BE USED IN CONTAMINATED ENVIRONMENTS IN CONCERT WITH A STANDARD NATO NBC CARTRIDGE FILTER ATTACHED TO THE AIR INLET ON THE BACK OF THE HAMILTON-T1 (NBC FILTER ADAPTER INSTRUCTION FOR USE, REF 161747, HAMILTON MEDICAL). THIS HEPA FILTER IMPROVES REMOVAL OF NBC CONTAMINATES FROM THE TRANSPORT VENTILATOR'S DELIVERED BREATHS TO THE PATIENT. LIKELY, DUE TO THIS INCREASED FILTRATION (RESISTANCE TO AIR FLOW) WHEN COUPLED WITH THE INCREASED DEMAND OF THE VENTILATOR ATTEMPTING TO DELIVER THE SET 100% OXYGEN CONCENTRATION, AND ON SEPTEMBER 10TH, 2024, HAMILTON MEDICAL AG ADDITIONALLY RECEIVED THE INFORMATION THAT THE INCIDENT RESULTED IN PATIENT DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504977 | HAMILTON-T1 | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | 161009 | 07630002806091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |