FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C2
MDR report key: 18692977
·
Received February 13, 2024
Report
- Report Number
- 3001421318-2024-00280
- Event Type
- Malfunction
- Date Received
- February 13, 2024
- Date of Event
- January 23, 2024
- Report Date
- November 8, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800372
- PMA / PMN Number
- K121225
- 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: DEFECIVE ESM BOARD. CORRECTION: REPLACED DEFECTIVE COMPONENT.
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: DEFECTIVE ESM BOARD. CORRECTION: REPLACED DEFECTIVE COMPONENT. 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.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TECHNICAL EVENT 232035, 232008 DUE TO MAINBOARD.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TECHNICAL EVENT 232035, 232008 DUE TO MAINBOARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2278906 | HAMILTON-C2 | HAMILTON-C2 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160001 | 07630002800372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |