HAMILTON-C3
Report
- Report Number
- 3001421318-2023-03457
- Event Type
- Malfunction
- Date Received
- October 5, 2023
- Date of Event
- September 22, 2023
- Report Date
- August 14, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002801881
- PMA / PMN Number
- K201306
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- 505
Narratives
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: LOSS OF EXTERNAL POWER DUE TO VOLTAGE FLUCTUATIONS/VARIATION, GND POWER ,+24PS DROP VOLTAGE FLUCTUATIONS 4 V AND UP 24 VOLT. GND POWER, +24 BLOWER VOLTAGE IS 30V. CORRECTION: REPLACED POWER SUPPLY.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: LOSS OF EXTERNAL POWER DUE TO VOLTAGE FLUCTUATIONS/VARIATION, GND POWER ,+24PS DROP VOLTAGE FLUCTUATIONS 4 V AND UP 24 VOLT. GND POWER, +24 BLOWER VOLTAGE IS 30V. CORRECTION: REPLACED POWER SUPPLY. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: LOSS OF EXTERNAL POWER DUE TO VOLTAGE FLUCTUATIONS/VARIATION, GND POWER ,+24PS DROP VOLTAGE FLUCTUATIONS 4 V AND UP 24 VOLT. GND POWER, +24 BLOWER VOLTAGE IS 30V. POWER SUPPLY IS DEFECTIVE.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: LOSS OF EXTERNAL POWER DUE TO VOLTAGE FLUCTUATIONS/VARIATION, GND POWER ,+24PS DROP VOLTAGE FLUCTUATIONS 4 V AND UP 24 VOLT. GND POWER, +24 BLOWER VOLTAGE IS 30V. POWER SUPPLY IS DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2272109 | HAMILTON-C3 | HAMILTON-C3 | CBK | HAMILTON MEDICAL AG | 160005 | 07630002801881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |