FDA Adverse Event
Malfunction
Summary report: N
PANORAMA CENTRAL STATION
MDR report key: 3091044
·
Received April 30, 2013
Report
- Report Number
- 2221819-2013-00830
- Event Type
- Malfunction
- Date Received
- April 30, 2013
- Date of Event
- March 24, 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
THE UNIT WAS RETURNED TO MINDRAY'S REPAIR CTR FOR REPAIR.
Description of Event or Problem · 1
CUSTOMER REPORTED AN ISSUE WITH THE PANORAMA CENTRAL STATION WHICH MAY HAVE RESULTED IN LOSS OF AMBULATORY TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186745 | PANORAMA CENTRAL STATION | CENTRAL MONITORING STATION | MHX | MINDRAY DS USA, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |