MAUDE Adverse Event Report: MINDRAY DS USA, INC SPECTRUM MONITOR AND PANORAMA CENTRAL STATION; PT MONITOR AND CENTRAL STATION

Device Problem Image Display Error/Artifact (1304)

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

Event Date 05/04/2014

Event Type  malfunction  

Event Description

Customer reported that the spectrum monitor did not display ecg wave form, which may have affected pt monitoring.No pt injury was reported.

Manufacturer Narrative

Documentation collected from customer and will be reviewed.

• Brand Name: SPECTRUM MONITOR AND PANORAMA CENTRAL STATION
• Type of Device: PT MONITOR AND CENTRAL STATION
• Manufacturer (Section D): MINDRAY DS USA, INC; mahwah NJ
• Manufacturer Contact: wisara sethachutkul ; 800 macarthur blvd.; mahwah, NJ 07430 ; 2019958045
• MDR Report Key: 3917791
• MDR Text Key: 4664544
• Report Number: 2221819-2014-00269
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 062098
• 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: 05/28/2014

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: Not provided
• Initial Date FDA Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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