FDA Adverse Event
Death
Summary report: N
CARESCAPE TELEMETRY SERVER
MDR report key: 2007061
·
Received February 24, 2011
Report
- Report Number
- 2124823-2011-00018
- Event Type
- Death
- Date Received
- February 24, 2011
- Date of Event
- January 28, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GE HEALTHCARE
- Product Code
- MHX
- PMA / PMN Number
- K080251
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PT INFO HAS NOT BEEN MADE AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
A SITE REPORTED TO GE HEALTHCARE THAT A PT EXPIRED WHILE BEING MONITORED ON A CARESCAPE TELEMETRY SERVER. THE SITE REQUESTED THAT GE PROVIDE A REVIEW OF THE LOG FILES FOR THE EVENT IN QUESTION. AN INITIAL LOG REVIEW INDICATES THE NUMEROUS SYSTEM ALARMS INCLUDING ARTIFACT, ARRHYTHMIA SUSPEND, AND LEADS FAIL WERE SOUNDED AND SILENCED DURING THE EVENT IN QUESTION. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARESCAPE TELEMETRY SERVER | TELEMETRY MONITORING SYSTEM | MHX | GE HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |