FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE INFUSION PUMP- ENGLISH
MDR report key: 20876103
·
Received December 9, 2024
Report
- Report Number
- 3010293992-2024-00068
- Event Type
- Malfunction
- Date Received
- December 9, 2024
- Date of Event
- November 14, 2024
- Report Date
- March 17, 2025
- Manufacturer
- EITAN MEDICAL LTD.
- Product Code
- FRN
- UDI-DI
- 7290109153339
- PMA / PMN Number
- K192860
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- 501
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: K192860.
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: K192860.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM BELGIUM. DELIVERY ISSUE.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM BELGIUM. DELIVERY ISSUE.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM BELGIUM. DELIVERY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328292 | SAPPHIRE INFUSION PUMP- ENGLISH | INFUSION PUMP | FRN | EITAN MEDICAL LTD. | 7290109153339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |