FDA Adverse Event
Malfunction
Summary report: N
PANORAMA CENTRAL STATION
MDR report key: 2980999
·
Received January 29, 2013
Report
- Report Number
- 2221819-2013-00034
- Event Type
- Malfunction
- Date Received
- January 29, 2013
- Date of Event
- October 8, 2012
- Report Date
- January 30, 2013
- Manufacturer
- MINDRAY DS USA, INC
- Product Code
- MHX
- PMA / PMN Number
- 011540
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP EVALUATED THE SYSTEM AND FOUND A FAILED MOTHER BOARD. CORRECTIONS INCLUDED REPLACEMENT OF THE SYSTEM'S MOTHER BOARD AND CLEARING OF ERROR LOGS. THE UNIT WAS TESTED TO FACTORY'S SPECS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE PANORAMA CENTRAL STATION HAD A BLANK SCREEN, WHICH MAY HAVE RESULTED IN A LOSS OF AMBULATORY TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39767 | PANORAMA CENTRAL STATION | NONE | MHX | MINDRAY DS USA, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |