FDA Adverse Event
Malfunction
Summary report: N
PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT
MDR report key: 1081044
·
Received July 18, 2008
Report
- Report Number
- 6000002-2008-08117
- Event Type
- Malfunction
- Date Received
- July 18, 2008
- Date of Event
- June 23, 2008
- Report Date
- June 26, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DQA
- PMA / PMN Number
- K053609
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, SVO2 VALUE WAS ABNORMAL. SVO2 MEASUREMENT VALUE WAS AROUND 50%, WHICH WAS 20% DIFFERENT COMPARED TO THE REAL SVO2 VALUE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT | CENTRAL VENOUS OXIMETRY KIT | DQA | EDWARDS LIFESCIENCES, PR | X3820HSJD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |