FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C6
MDR report key: 18117757
·
Received November 13, 2023
Report
- Report Number
- 3001421318-2023-03826
- Event Type
- Malfunction
- Date Received
- November 13, 2023
- Date of Event
- October 27, 2023
- Report Date
- August 15, 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
- 505
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: DEFECTIVE INSPIRATORY VALVE. CORRECTION: REPLACE INSPIRATORY VALVE. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WERE UPDATED WITH FULL UDI INFORMATION AS REQUESTED. UPDATED FIELDS: B4, D1, D4, G3, G6, H2 AND H4.
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: DEFECTIVE INSPIRATORY VALVE. CORRECTION: REPLACE INSPIRATORY VALVE.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TF 231005 DURING OPERATION ON (B)(6) 2023 AT 23:22:08.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TF 231005 DURING OPERATION ON (B)(6) 2023 AT 23:22:08.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2108935 | HAMILTON-C6 | HAMILTON-C6 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |