FDA Adverse Event
Malfunction
Summary report: N
SAPPHIREPLUS INFUSION PUMP
MDR report key: 13010474
·
Received December 15, 2021
Report
- Report Number
- 3010293992-2021-00063
- Event Type
- Malfunction
- Date Received
- December 15, 2021
- Date of Event
- November 15, 2021
- Report Date
- February 6, 2022
- Manufacturer
- EITAN MEDICAL LTD
- Product Code
- FRN
- UDI-DI
- 07290109150161
- PMA / PMN Number
- K161667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- 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 3010293992.
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 USA. DELIVERY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1909510 | SAPPHIREPLUS INFUSION PUMP | INFUSION PUMP | FRN | EITAN MEDICAL LTD | 07290109150161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |