FDA Adverse Event
Malfunction
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 16851474
·
Received May 2, 2023
Report
- Report Number
- 3001421318-2023-01603
- Event Type
- Malfunction
- Date Received
- May 2, 2023
- Date of Event
- April 24, 2023
- Report Date
- May 2, 2023
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800372
- PMA / PMN Number
- K121225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG`S CONCLUSION: FAILURE MODE DESCRIPTION: - DEVICE ALARMS WITH TF 232006 (BLOW ER TEMPERATURE SENSOR DEFECT) DURING START-UP. FAILURE EFFECT: DEVICE ALARMS WITH TF 232006 (BLOW ER TEMPERATURE SENSOR DEFECT) DURING START-UP. ROOT CAUSE: BLOWER TEMPERATURE SENSOR CABLE NOT PROPERLY CONNECTED TO MAINBOARD. CORRECTION: RECONNECTION FLAT CABLE TO MAINBOARD CONNECTOR.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DEVICE ALARMS WITH TF 232006 (BLOW ER TEMPERATURE SENSOR DEFECT) DURING START-UP STARTUP FAILED. THE C2 WAS CONNECTED TO THE PDMS WHEN THE FIRST THE ERROR OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 246645 | HAMILTON MEDICAL AG | HAMILTON-C2 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160001 | 07630002800372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |