FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C3
MDR report key: 18450342
·
Received January 5, 2024
Report
- Report Number
- 3001421318-2024-00035
- Event Type
- Malfunction
- Date Received
- January 5, 2024
- Date of Event
- December 14, 2023
- Report Date
- October 28, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002801881
- PMA / PMN Number
- K201306
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: DEFECTIVE BUZZER (MAINBOARD). CORRECTION: REPLACE MAINBOARD.
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: DEFECTIVE BUZZER (MAINBOARD). CORRECTION: REPLACE MAINBOARD. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4).
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:TF 243004 (BUZZER DEFECT AT STARTUP).
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TF 243004 (BUZZER DEFECT AT STARTUP).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1549971 | HAMILTON-C3 | HAMILTON-C3 | CBK | HAMILTON MEDICAL AG | 160005 | 07630002801881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |