FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C3
MDR report key: 18118111
·
Received November 13, 2023
Report
- Report Number
- 3001421318-2023-03835
- Event Type
- Malfunction
- Date Received
- November 13, 2023
- Date of Event
- October 27, 2023
- Report Date
- October 31, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002801881
- PMA / PMN Number
- K201306
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 505
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). UDI RELATED DATA QUALITY UPDATES ONLY: FIELD D4 WERE UPDATED WITH FULL UDI INFORMATION AS REQUESTED.
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: SEE CER (B)(4).
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:TF (B)(4) BATTERY COMMUNICATION ERROR DURING START-UP.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:TF 431008, 231012, 231023, BATTERY COMMUNICATION ERROR DURING START-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236707 | HAMILTON-C3 | HAMILTON-C3 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160005 | 07630002801881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |