FDA Adverse Event
Other
Summary report: N
SC7000
MDR report key: 951621
·
Received November 19, 2007
Report
- Report Number
- 1220063-2007-00034
- Event Type
- Other
- Date Received
- November 19, 2007
- Date of Event
- September 10, 2007
- Report Date
- November 13, 2007
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC.
- Product Code
- DSI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE HAVE REQUESTED THE RETURN OF THE CITED MONITOR AND ASSOCIATED MATERIALS USED ON THE PATIENT AT THE TIME OF THE REPORTED EVENT.
Description of Event or Problem · 1
DRAEGER MEDICAL SYSTEMS HAS RECEIVED INFORMATION FROM A CUSTOMER THAT A PATIENT EVENT OCCURRED WHILE BEING MONITORED FOR CVP, (CENTRAL VENOUS PRESSURE) USING OUR SC7000 MONITOR AND HEMOMED POD. THE USER REPORTED, THAT A NEAR INCIDENT OCCURRED WHICH RESULTED IN THE INABILITY TO DETERMINE THE PATIENT'S ARTERIAL BLOOD PRESSURE AND REQUIRED INTERVENTION TO NORMALIZE THE PATIENT'S CONDITION. THE USER FACILITY REPORTED, THAT THE PATIENT RECOVERED WITHOUT FURTHER REPORTS OF AN ADVERSE OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SC7000 | PATIENT MONITOR | DSI | DRAEGER MEDICAL SYSTEMS, INC. | 5203000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Life Threatening| R |