FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE M.T INFUSION PUMP - GERMAN
MDR report key: 12959103
·
Received December 8, 2021
Report
- Report Number
- 3010293992-2021-00061
- Event Type
- Malfunction
- Date Received
- December 8, 2021
- Date of Event
- November 6, 2021
- Report Date
- February 14, 2022
- Manufacturer
- EITAN MEDICAL LTD.
- Product Code
- FRN
- PMA / PMN Number
- K192860
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
EITAN MEDICAL LTD IS FORMERLY NAMED Q CORE MEDICAL LTD. THE FEI NUMBER IS THE SAME: (B)(4).
Additional Manufacturer Narrative · 0
EITAN MEDICAL LTD IS FORMERLY NAMED Q CORE MEDICAL LTD. THE FEI NUMBER IS THE SAME (B)(4).
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM GERMANY. DELIVERY ISSUE.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM (B)(6): DELIVERY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1860414 | SAPPHIRE M.T INFUSION PUMP - GERMAN | INFUSION PUMP | FRN | EITAN MEDICAL LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |