FDA Adverse Event
Malfunction
Summary report: N
PANORAMA
MDR report key: 1181051
·
Received September 29, 2008
Report
- Report Number
- 2221819-2008-00041
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- July 2, 2008
- Report Date
- July 2, 2008
- Manufacturer
- MINDRAY DS USA, INC.
- Product Code
- DRT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE CLEARED THE SYSTEM ERROR LOGS AND RESET THE SYSTEM, BUT THE SYSTEM WENT TO A BLUE SCREEN AGAIN SEVERAL HOURS LATER. THE COMPANY REPRESENTATIVE REPLACED BOTH SYSTEM HARD DRIVES. THE SYSTEM WAS TESTED ACCORDING TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE PANORAMA CENTRAL STATION WAS IN USE MONITORING PTS ALONG WITH TELEPACKS, THE CENTRAL STATION WENT TO A BLUE SCREEN. THE CUSTOMER STATED THAT THIS HAD HAPPENED SIX TIMES PREVIOUSLY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PANORAMA | PATIENT MONITORING NETWORK | DRT | MINDRAY DS USA, INC. | PANORAMA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |