FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE INFUSION PUMP- ENGLISH
MDR report key: 9745207
·
Received February 24, 2020
Report
- Report Number
- 3010293992-2020-00007
- Event Type
- Malfunction
- Date Received
- February 24, 2020
- Report Date
- February 24, 2020
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- FRN
- PMA / PMN Number
- K161667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER, E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL.
Additional Manufacturer Narrative · 0
G.1 DISTRIBUTOR INFORMATION: ICU MEDICAL, INC. US SERVICE CENTER (B)(4). EXEMPTION NUMBER, E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL.
Description of Event or Problem · 0
THE COMPLIANT WAS REPORTED BY A CUSTOMER FROM (B)(6). BROKEN PUMP.
Description of Event or Problem · 0
THE COMPLIANT WAS REPORTED BY A CUSTOMER FROM AUSTRALIA. BROKEN PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210337 | SAPPHIRE INFUSION PUMP- ENGLISH | INFUSION PUMP | FRN | Q CORE MEDICAL LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |