FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE M.T INFUSION PUMP - COLOMBIA (SPANISH)
MDR report key: 13548585
·
Received February 17, 2022
Report
- Report Number
- 3010293992-2022-00003
- Event Type
- Malfunction
- Date Received
- February 17, 2022
- Report Date
- March 28, 2022
- Manufacturer
- EITAN MEDICAL LTD
- Product Code
- FRN
- PMA / PMN Number
- K192860
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- 003
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 USA. 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 |
|---|---|---|---|---|---|---|---|
| 1759945 | SAPPHIRE M.T INFUSION PUMP - COLOMBIA (SPANISH) | INFUSION PUMP | FRN | EITAN MEDICAL LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |