FDA Adverse Event
Malfunction
Summary report: N
SAPPHIRE EPIDURAL INFUSION PUMP SPANISH
MDR report key: 9320893
·
Received November 14, 2019
Report
- Report Number
- 3010293992-2019-00097
- Event Type
- Malfunction
- Date Received
- November 14, 2019
- Date of Event
- September 3, 2019
- Report Date
- October 15, 2019
- Manufacturer
- Q CORE MEDICAL LTD.
- Product Code
- FRN
- PMA / PMN Number
- K161667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PE
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
"(B)(4). EXEMPTION NUMBER, E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL."
Additional Manufacturer Narrative · 0
"G.1 DISTRIBUTOR INFORMATION: ICU MEDICAL, INC. US SERVICE CENTER (B)(4). EXEMPTION NUMBER, E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL."
Description of Event or Problem · 0
THE COMPLIANT WAS REPORTED BY A CUSTOMER FROM (B)(6). DELIVERY ISSUE.
Description of Event or Problem · 0
THE COMPLIANT WAS REPORTED BY A CUSTOMER FROM PERU DELIVERY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1120010 | SAPPHIRE EPIDURAL INFUSION PUMP SPANISH | INFUSION PUMP | FRN | Q CORE MEDICAL LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |