FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE M.T INFUSION PUMP - FRENCH
MDR report key: 8896176
·
Received August 15, 2019
Report
- Report Number
- 3010293992-2019-00063
- Event Type
- Malfunction
- Date Received
- August 15, 2019
- Report Date
- July 18, 2019
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- FRN
- PMA / PMN Number
- K161667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
(B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL. EXEMPTION NUMBER, E2014005.
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 COMPLAINT WAS REPORTED BY A CUSTOMER FROM (B)(6): DELIVERY ISSUE.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE: DELIVERY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690044 | SAPPHIRE M.T INFUSION PUMP - FRENCH | INFUSION PUMP | FRN | Q CORE MEDICAL LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |