FDA Adverse Event
Malfunction
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 16563648
·
Received March 17, 2023
Report
- Report Number
- 3001421318-2023-00744
- Event Type
- Malfunction
- Date Received
- March 17, 2023
- Date of Event
- February 23, 2023
- Report Date
- April 9, 2024
- 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
ANALYSIS ONGOING. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 0
A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE AND WAS DEEMED NON-REPORTABLE. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING THE USE OF THIS EQUIPMENT IN THE ICU OF THE HOSPITAL, THE MACHINE REPORTED AN ERROR, AND THE TECHNICAL EVENT WAS 231022. NO CONSEQUENCES FOR A PATIENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING THE USE OF THIS EQUIPMENT IN THE ICU OF THE HOSPITAL, THE MACHINE REPORTED AN ERROR, AND THE TECHNICAL EVENT WAS 231022. NO CONSEQUENCES FOR A PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 824816 | HAMILTON MEDICAL AG | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | HAMILTON-C1 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |