FDA Adverse Event
Malfunction
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 16884222
·
Received May 8, 2023
Report
- Report Number
- 3001421318-2023-01628
- Event Type
- Malfunction
- Date Received
- May 8, 2023
- Date of Event
- April 15, 2023
- Report Date
- May 8, 2023
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800747
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED TO HAMILTON MEDICAL AG: DURING THE USE OF THIS EQUIPMENT IN THE HOSPITAL TRAUMA ICU, THE EQUIPMENT REPORTED AN ERROR AND PREVENTIVE MAINTENANCE WAS REQUIRED. PATIENT HARM IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 582147 | HAMILTON MEDICAL AG | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | 161001 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |