FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C3
MDR report key: 18289513
·
Received December 8, 2023
Report
- Report Number
- 3001421318-2023-04116
- Event Type
- Malfunction
- Date Received
- December 8, 2023
- Date of Event
- October 14, 2023
- Report Date
- October 18, 2024
- 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
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: MAINBOARD DEFECTIVE CORRECTION: REPLACED MAINBOARD 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.
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: MAINBOARD DEFECTIVE CORRECTION: REPLACED MAINBOARD.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TF 431008, 231012, 231023 DURING START-UP.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TF 431008, 231012, 231023 DURING START-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1127947 | HAMILTON-C3 | HAMILTON-C3 | CBK | HAMILTON MEDICAL AG | 160005 | 07630002801881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |