FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE M.T INFUSION PUMP - FRENCH
MDR report key: 9726344
·
Received February 19, 2020
Report
- Report Number
- 3010293992-2020-00006
- Event Type
- Malfunction
- Date Received
- February 19, 2020
- Report Date
- April 1, 2020
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- FRN
- PMA / PMN Number
- K161667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). 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). DELIVERY ISSUE.
Description of Event or Problem · 0
THE COMPLIANT WAS REPORTED BY A CUSTOMER FROM FRANCE. DELIVERY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 190082 | SAPPHIRE M.T INFUSION PUMP - FRENCH | INFUSION PUMP | FRN | Q CORE MEDICAL LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |