FDA Adverse Event
Malfunction
Summary report: N
PANORAMA CENTRAL STATION
MDR report key: 3091856
·
Received April 30, 2013
Report
- Report Number
- 2221819-2013-00979
- Event Type
- Malfunction
- Date Received
- April 30, 2013
- Date of Event
- April 8, 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
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED CLEARING OF SYSTEM'S ERROR LOGS, REBOOTING, AND REPLACEMENT OF THE PATCH CABLE IN RACK ROOM. SYSTEM WAS TESTED TO FACTORY'S SPECIFICATION.
Description of Event or Problem · 1
CUSTOMER REPORTED THE PANORAMA CENTRAL STATION HAD AN ERROR MESSAGE, WHICH MAY HAVE RESULTED IN LOSS OF TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 187085 | PANORAMA CENTRAL STATION | CENTRAL MONITORING STATION | MHX | MINDRAY DS USA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |