FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C1
MDR report key: 18053919
·
Received November 2, 2023
Report
- Report Number
- 3001421318-2023-03716
- Event Type
- Malfunction
- Date Received
- November 2, 2023
- Date of Event
- October 16, 2023
- Report Date
- November 14, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800747
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- 505
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TECHNICAL ERROR 232035 DURING START-UP (PFILTER SELFTEST FAILED). NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TECHNICAL ERROR 232035 DURING START-UP (PFILTER SELFTEST FAILED). NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154644 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | 161001 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |