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