HAMILTON-T1
Report
- Report Number
- 3001421318-2024-01105
- Event Type
- Malfunction
- Date Received
- May 7, 2024
- Date of Event
- April 23, 2024
- Report Date
- December 29, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002801850
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H11.
HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION ONGOING.
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING. 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. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE INVESTIGATION SHOWED THAT WHEN THE VENTILATOR WAS BEING PREPARED FOR USE THE DEVICE STARTED GIVING ALARMS OF LOW OXYGEN. THE O2 CELL FUNCTIONS LIKE A BATTERY. ITS PERFORMANCE DECREASES THE MORE IT IS USED. THEREFORE, O2 CELLS NEED TO BE MAINTAINED REGULARLY. IF THE O2 CELL CANNOT DELIVER THE REQUIRED AMOUNT OF OXYGEN SET BY THE USER THEN THE DEVICE NOTIFIES THE USER BY GIVING AN ALARM. THIS IS WHAT HAPPENED IN THIS INCIDENT. THE DEVICE DID WHAT IT WAS SUPPOSED TO DO. THERE WAS NO MALFUNCTION AND THEREFORE THIS CASE IS NOT REPORTABLE.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE ALARMED FOR LOW OXYGEN. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. WE LACK FURTHER INFORMATION ON THIS. AN INTERMITTENT ALARM WAS OBSERVABLE BOTH VISUALLY (MESSAGE ALERT: 'LOW OXYGEN') AND THROUGH HEARING. THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG. THERE IS PATIENT INVOLVEMENT REPORTED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION BUT WAS NOT FURTHER SPECIFIED NOR EXPLAINED. 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 STILL ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE ALARMED FOR LOW OXYGEN. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. WE LACK FURTHER INFORMATION ON THIS. AN INTERMITTENT ALARM WAS OBSERVABLE BOTH VISUALLY (MESSAGE ALERT: 'LOW OXYGEN') AND THROUGH HEARING. THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG. THERE IS PATIENT INVOLVEMENT REPORTED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION BUT WAS NOT FURTHER SPECIFIED NOR EXPLAINED. 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 STILL ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE ALARMED FOR LOW OXYGEN. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. WE LACK FURTHER INFORMATION ON THIS. AN INTERMITTENT ALARM WAS OBSERVABLE BOTH VISUALLY (MESSAGE ALERT: 'LOW OXYGEN') AND THROUGH HEARING. THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG. THERE IS PATIENT INVOLVEMENT REPORTED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION BUT WAS NOT FURTHER SPECIFIED NOR EXPLAINED. 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 STILL ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 641751 | HAMILTON-T1 | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | 161006 | 07630002801850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |