FDA Adverse Event
Malfunction
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 17478028
·
Received August 8, 2023
Report
- Report Number
- 3001421318-2023-02833
- Event Type
- Malfunction
- Date Received
- August 8, 2023
- Date of Event
- July 26, 2023
- Report Date
- August 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
- 505
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 REPORT FROM HOSPITAL SAY: ON (B)(6), 2023, THE DEPARTMENT OF INTENSIVE CARE MEDICINE IN THE OLD HOSPITAL AREA REPORTED TO THE MEDICAL EQUIPMENT DEPARTMENT FOR REPAIR AND TRANSFER OF A VENTILATOR. THE FAILURE OF THE EQUIPMENT WAS SHOWN AS: THE BATTERY WAS DEAD AFTER BEING PLUGGED IN NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695725 | HAMILTON MEDICAL AG | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | HAMILTON-C1 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |