FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C1
MDR report key: 18938765
·
Received March 20, 2024
Report
- Report Number
- 3001421318-2024-00659
- Event Type
- Malfunction
- Date Received
- March 20, 2024
- Date of Event
- February 22, 2024
- Report Date
- October 28, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002813426
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4).
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 C1 HAD BEEN STORED IN THE HOSPITAL WAREHOUSE FOR ABOUT SIX MONTHS SINCE ITS PURCHASE. WHEN THE C1 BECAME OPERATIONAL, THE HOSPITAL STAFF CHECKED IT AND TECHNICAL EVENT:232003 (PAW SENSOR DEFECT) OCCURRED. NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE C1 HAD BEEN STORED IN THE HOSPITAL WAREHOUSE FOR ABOUT SIX MONTHS SINCE ITS PURCHASE. WHEN THE C1 BECAME OPERATIONAL, THE HOSPITAL STAFF CHECKED IT AND TECHNICAL EVENT: 232003 (PAW SENSOR DEFECT) OCCURRED. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535723 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | 1610010 | 07630002813426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |