FDA Adverse Event
Malfunction
Summary report: N
SOLAR 8000
MDR report key: 1950295
·
Received December 14, 2010
Report
- Report Number
- 2124823-2010-00131
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- November 15, 2010
- Report Date
- December 14, 2010
- Manufacturer
- GE HEALTHCARE
- Product Code
- MHX
- PMA / PMN Number
- K071073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DATE OF MANUFACTURE IS NOT AVAILABLE WITHOUT A VALID SERIAL NUMBER.
Description of Event or Problem · 1
A SITE REPORTED THAT THE MONITOR DID NOT ALARM WHEN A PATIENT ALLEGEDLY WENT INTO VENTRICULAR TACHYCARDIA. THE HOSPITAL STAFF REPORTEDLY WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. 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 8000 | PATIENT MONITOR | MHX | GE HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |