FDA Adverse Event Malfunction Summary report: N

PANORAMA CENTRAL STATION

MDR report key: 3091789 · Received April 30, 2013

Report

Report Number
2221819-2013-01087
Event Type
Malfunction
Date Received
April 30, 2013
Date of Event
April 22, 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

COMPANY REP EVALUATED THE SYSTEM. CORRECTIONS INCLUDED RESETTING OF THE SYSTEM'S TOWER AND COMMUNICATION WAS REESTABLISHED.

Description of Event or Problem · 1

CUSTOMER REPORTED THE PANORAMA CENTRAL STATION HAD LOST COMMUNICATION, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
188122 PANORAMA CENTRAL STATION CENTRAL STATION MONITOR MHX MINDRAY DS USA, INC.

Patients

Seq Age Sex Outcome Treatment
1