FDA Adverse Event
Malfunction
Summary report: N
PANORAMA CENTRAL STATION
MDR report key: 3102666
·
Received May 1, 2013
Report
- Report Number
- 2221819-2013-01064
- Event Type
- Malfunction
- Date Received
- May 1, 2013
- Date of Event
- April 17, 2013
- Report Date
- April 30, 2013
- Manufacturer
- MINDRAY DS USA, INC.
- Product Code
- MHX
- PMA / PMN Number
- 031760
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE CPU FAN AND MOUNT. SYSTEM WAS REBOOTED AND OPERATED NORMALLY.
Description of Event or Problem · 1
CUSTOMER REPORTED THE PANORAMA CENTRAL STATION SHUT DOWN, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189512 | PANORAMA CENTRAL STATION | CENTRAL MONITORING STATION | MHX | MINDRAY DS USA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |