FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C2
MDR report key: 18008974
·
Received October 26, 2023
Report
- Report Number
- 3001421318-2023-03655
- Event Type
- Malfunction
- Date Received
- October 26, 2023
- Date of Event
- October 5, 2023
- Report Date
- August 9, 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: O2 MIXER ASSEMBLY DEFECTIV. CORRECTION: O2 MIXER ASSEMBLY REPLACED. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (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.
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: O2 MIXER ASSEMBLY DEFECTIV. CORRECTION: O2 MIXER ASSEMBLY REPLACED.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:TF 231013 QO2 FLOW SENSOR DEFECT. SELFTEST AT START UP NOT PASSED.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:TF 231013 QO2 FLOW SENSOR DEFECT. SELFTEST AT START UP NOT PASSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1567057 | HAMILTON-C2 | HAMILTON-C2 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160001 | 07630002800372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |