HAMILTON-C6
Report
- Report Number
- 3001421318-2023-03688
- Event Type
- Malfunction
- Date Received
- October 31, 2023
- Date of Event
- October 3, 2023
- Report Date
- August 9, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 505
Narratives
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: FROM THE INFORMATION RECEIVED AND THE ANALYSIS PERFORMED REGARDING THIS CASE, THE MOST PROBABLE ROOT CAUSE IS A DEFECTIVE REAR FAN. THE SERVICE TECHNICIAN REPLACED THE REAR FAN PN 160639 TO SOLVE THE ISSUE AND PERFORMED THE COMPLETE SERVICE SOFTWARE. THE VENTILATOR WAS THEN RELEASED FOR USE ON PATIENTS.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: SEE 143413.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: FROM THE INFORMATION RECEIVED AND THE ANALYSIS PERFORMED REGARDING THIS CASE, THE MOST PROBABLE ROOT CAUSE IS A DEFECTIVE REAR FAN. THE SERVICE TECHNICIAN REPLACED THE REAR FAN PN 160639 TO SOLVE THE ISSUE AND PERFORMED THE COMPLETE SERVICE SOFTWARE. THE VENTILATOR WAS THEN RELEASED FOR USE ON PATIENTS. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 2 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WERE UPDATED WITH FULL UDI INFORMATION AS REQUESTED.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: FAN FAILURE.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: FAN FAILURE.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: FAN FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2223033 | HAMILTON-C6 | HAMILTON-C6 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |