MAUDE Adverse Event Report: MINDRAY DS USA, INC. PANORAMA CENTRAL STATION WITH TELEPACK; CENTRAL STATION MONITOR

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Company representative evaluated the system and replaced power module.

• Brand Name: PANORAMA CENTRAL STATION WITH TELEPACK
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): MINDRAY DS USA, INC.; mahwah NJ
• Manufacturer Contact: wisara sethachutkul ; 800 macarthur blvd.; mahwah, NJ 07430 ; 2019958045
• MDR Report Key: 3795411
• MDR Text Key: 4366400
• Report Number: 2221819-2014-00110
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031760
• 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: 03/06/2014

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: 03/06/2014
• Initial Date FDA Received: 03/28/2014
• 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