FDA Adverse Event
Malfunction
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 17224720
·
Received June 29, 2023
Report
- Report Number
- 3001421318-2023-02496
- Event Type
- Malfunction
- Date Received
- June 29, 2023
- Date of Event
- June 6, 2023
- Report Date
- June 29, 2023
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800747
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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: THE HOSPITAL STAFF PLANNED TO PERFORM MAINTENANCE ON THIS C1. HOWEVER, AFTER REPEATED ATTEMPTS TO CALIBRATE THE FLOW SENSOR RESULTED IN NG, THEY GAVE UP ON THE MAINTENANCE. WHEN WE CHECKED AGAIN THE NEXT DAY, TECHNICAL EVENT: 231003 WAS ALSO DISPLAYED ON THE SCREEN. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309533 | HAMILTON MEDICAL AG | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | HAMILTON-C1 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |