MAUDE Adverse Event Report: MINDRAY DS USA, INC PANORAMA CENTRAL STATION WITH TELEMETRY; CENTRAL MONITORING STATION

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2014

Event Type  malfunction  

Event Description

Customer reported an issue with the panorama central station's display, which may have affected telemetry monitoring.No pt injury was reported.

Manufacturer Narrative

Company rep evaluated unit and verified the problem.Corrections include replacement of the lcd module and repairing the power board.

• Brand Name: PANORAMA CENTRAL STATION WITH TELEMETRY
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): MINDRAY DS USA, INC; mahwah NJ
• Manufacturer Contact: wisara sethachutkul ; 800 macarthur blvd.; mahwah, NJ 07430 ; 2019958045
• MDR Report Key: 4217069
• MDR Text Key: 5042375
• Report Number: 2221819-2014-00798
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 031760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1