FDA Adverse Event
Malfunction
Summary report: N
PANORAMA CENTRAL STATION
MDR report key: 3102687
·
Received May 1, 2013
Report
- Report Number
- 2221819-2013-01037
- Event Type
- Malfunction
- Date Received
- May 1, 2013
- Date of Event
- March 20, 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
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
COMPANY REP INSTRUCTED THE CUSTOMER TO ADJUST THE SYSTEM'S CABLE TO AN ADJACENT PORT AND COMMUNICATION WAS RESTORED.
Description of Event or Problem · 1
CUSTOMER REPORTED LOSS OF COMMUNICATION BETWEEN THE PANORAMA CENTRAL STATION AND AMBULATORY TELEPACKS, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189396 | PANORAMA CENTRAL STATION | CENTRAL MONITORING STATION | MHX | MINDRAY DS USA, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |