FDA Adverse Event Malfunction Summary report: N

PANORAMA CENTRAL STATION

MDR report key: 3102639 · Received May 1, 2013

Report

Report Number
2221819-2013-01049
Event Type
Malfunction
Date Received
May 1, 2013
Date of Event
April 15, 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

SYSTEM IS BEING RETURNED TO THE COMPANY'S NATIONAL REPAIR CENTER FOR REPAIR.

Description of Event or Problem · 1

CUSTOMER REPORTED THE PANORAMA CENTRAL STATION DISPLAYED A BLANK SCREEN, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
190399 PANORAMA CENTRAL STATION CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

Patients

Seq Age Sex Outcome Treatment
1