FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE M.T INFUSION PUMP - FRENCH
MDR report key: 20998444
·
Received December 23, 2024
Report
- Report Number
- 3010293992-2024-00070
- Event Type
- Malfunction
- Date Received
- December 23, 2024
- Date of Event
- December 8, 2024
- Report Date
- April 1, 2025
- Manufacturer
- EITAN MEDICAL LTD.
- Product Code
- FRN
- UDI-DI
- 7290109150710
- PMA / PMN Number
- K161667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K161667.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. 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 |
|---|---|---|---|---|---|---|---|
| 2627893 | SAPPHIRE M.T INFUSION PUMP - FRENCH | INFUSION PUMP | FRN | EITAN MEDICAL LTD. | 7290109150710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |