HAMILTON-T1
Report
- Report Number
- 3001421318-2024-01165
- Event Type
- Malfunction
- Date Received
- May 17, 2024
- Date of Event
- May 6, 2024
- Report Date
- January 3, 2025
- 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 (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: 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: DEVICE LOGS WERE NOT PROVIDED. THE INVESTIGATION WAS DONE BASED ON THE ANALYSIS OF THE TECHNICIAN ON SITE. THE ALARM "LOW OXYGEN" CAN HAVE SEVERAL REASONS SUCH AS TEMPERATURE INFLUENCE OR AN EXPIRED O2 CELL. THE O2 CELL WAS REPLACED BUT THE ISSUE REMAINED. THEN THE O2 MIXER ASSEMBLY (PART N° MSP161609) WAS REPLACED AND THE DEVICE FUNCTIONED AS INTENDED AGAIN. THEREFORE, THE ROOT CAUSE WAS CONFIRMED TO BE A DEFECTIVE O2 MIXER ASSEMBLY. THE MALFUNCTION OF THE O2 MIXER ASSEMBLY CAN CAUSE THE VENTILATOR NOT TO REACH THE REQUIRED OXYGEN LEVEL. IN THIS CASE THE DEVICE NOTIFIES THE USER BY GIVING AN ALARM "LOW OXYGEN". IF THE USER DOES NOT REACT ACCORDINGLY TO THE ALARM A DETERIORATION OF THE STATE OF HEALTH OF THE PATIENT CANNOT BE EXCLUDED. THEREFORE, THIS CASE WAS ASSESSED AS BEING REPORTABLE.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE DID NOT REACH 100% O2. - THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. - WHETHER ALARMS WERE TRIGGERED WAS NOT REPORTED. - THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG. - THIS MALFUNCTIONING WAS REPRODUCIBLE. - 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 DID NOT REACH 100% O2. - THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. - WHETHER ALARMS WERE TRIGGERED WAS NOT REPORTED. - THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG. - THIS MALFUNCTIONING WAS REPRODUCIBLE. - 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 DID NOT REACH 100% O2. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. WHETHER ALARMS WERE TRIGGERED WAS NOT REPORTED. THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG. THIS MALFUNCTIONING WAS REPRODUCIBLE. 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 |
|---|---|---|---|---|---|---|---|
| 2519695 | HAMILTON-T1 | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | 161006 | 07630002801850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |