FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C3
MDR report key: 20105078
·
Received August 30, 2024
Report
- Report Number
- 3001421318-2024-02098
- Event Type
- Malfunction
- Date Received
- August 30, 2024
- Date of Event
- August 22, 2024
- Report Date
- August 30, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- PMA / PMN Number
- K201306
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: "DURING THE TIME OF CALIBRATION IN THE SERVICE SOFTWARE TF 231005 OCCURED, AND THE INSPIRATION VALVE LEAK ISSUE. BUT IN THE VENTILATOR , THE MACHINE IS WORKING IN GOOD CONDITION WITHOUT ERROR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1912188 | HAMILTON-C3 | HAMILTON-C3 | CBK | HAMILTON MEDICAL AG | 160005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |