FDA Adverse Event
Malfunction
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 17209665
·
Received June 27, 2023
Report
- Report Number
- 3001421318-2023-02465
- Event Type
- Malfunction
- Date Received
- June 27, 2023
- Date of Event
- June 6, 2023
- Report Date
- June 27, 2023
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002813549
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TRANSLATED FROM GERMAN TO ENGLISH: HAMILTON SHOWS ERRORS TE 231013 AND 231023 AS WELL AS TF 431009 IN STANDBY LEAK TEST FAILS AND THE FLOW SENSOR CANNOT BE CALIBRATED EITHER. ERROR 231013 KEEPS POPPING UP NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772013 | HAMILTON MEDICAL AG | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | HAMILTON-T1 | 07630002813549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |