FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C6
MDR report key: 19283085
·
Received May 9, 2024
Report
- Report Number
- 3001421318-2024-01125
- Event Type
- Malfunction
- Date Received
- May 9, 2024
- Date of Event
- May 7, 2024
- Report Date
- October 2, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: INSPIRATION VALVE DEFECTIVE. 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.
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: INSPIRATION VALVE DEFECTIVE. CORRECTION: REPLACED DEFECTIVE COMPONENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: (B)(4).
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TE 231005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771580 | HAMILTON-C6 | HAMILTON-C6 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |