FDA Adverse Event
Malfunction
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 17647893
·
Received August 30, 2023
Report
- Report Number
- 3001421318-2023-03059
- Event Type
- Malfunction
- Date Received
- August 30, 2023
- Date of Event
- August 17, 2023
- Report Date
- August 30, 2023
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800372
- PMA / PMN Number
- K201658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL COMES TO THE FOLLOWING CONCLUSION: SEE CER 141796.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: THE HOSPITAL STAFF SAID, THAT THIS C2 WAS OFF AND WAITING IN A HALLWAY AND ALL OF A SUDDEN IT STARTED BLINKING AND BEEPING AND IT WAS LIKE THIS UNTILL THEY TOOK OUT THE BATTERIE. SO, WHEN THE POWER IS AVALIABLE, IT IS BLINKING AND BEEPING AND YOU CAN NOT DO ANYTHING WITH IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1679246 | HAMILTON MEDICAL AG | HAMILTON-C2 VENTILATOR | CBK | HAMILTON MEDICAL AG | 07630002800372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |