FDA Adverse Event
Malfunction
Summary report: N
CARESCAPE MONITOR B650
MDR report key: 2852756
·
Received November 14, 2012
Report
- Report Number
- 9610105-2012-00043
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 13, 2012
- Report Date
- October 15, 2012
- Manufacturer
- GE HEALTHCARE FINLAND OY
- Product Code
- MHX
- PMA / PMN Number
- K102239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE CARESCAPE B650 MONITOR WAS REBOOTED FOR THREE CYCLES RESULTING IN AN ERROR MESSAGE. THE MONITOR WAS NOT ABLE TO REGAIN FUNCTIONALITY DURING THE EVENT. THE CRITICALLY ILL PATIENT WAS TRANSFERRED TO ANOTHER MONITOR. THE PATIENT WAS A DO NOT RESUSCITATE STATUS AND EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARESCAPE MONITOR B650 | MULTI-PARAMETER PATIENT MONITOR | MHX | GE HEALTHCARE FINLAND OY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 YR |