FDA Adverse Event
Malfunction
Summary report: N
SOLAR 8000I
MDR report key: 1222863
·
Received November 6, 2008
Report
- Report Number
- 2124823-2008-00082
- Event Type
- Malfunction
- Date Received
- November 6, 2008
- Date of Event
- October 13, 2008
- Report Date
- November 6, 2008
- Manufacturer
- GE HEALTHCARE
- Product Code
- DRT
- PMA / PMN Number
- K053121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SOLAR 8000I ALLEGEDLY SHOWED NIBP READINGS IN THE 60'S. THE CLINICAL STAFF BEGAN TREATING WITH PT. AN ARTERIAL LINE WAS INSERTED AND IT WAS DISCOVERED THAT THE PT HAD AN ACTUAL SBP OF 170. NO PT INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLAR 8000I | PATIENT MONITOR | DRT | GE HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |