MAUDE Adverse Event Report: MINDRAY DS USA, INC. SPECTRUM MONITOR; PATIENT MONITOR

Device Problem Image Display Error/Artifact (1304)

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

Event Date 04/10/2014

Event Type  malfunction  

Event Description

Customer reported issue with the spectrum monitor's display, which may have affected patient monitoring.No patient injury was reported.

Manufacturer Narrative

Company representative evaluated the unit.Corrections included replacements of the unit's encoder and fan.Problem was resolved.

• Brand Name: SPECTRUM MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): MINDRAY DS USA, INC.; 800 macarthur blvd.; mahwah NJ
• Manufacturer Contact: wisara sethachutkul ; 800 macarthur blvd.; mahwah, NJ 07430-0619 ; 2019958045
• MDR Report Key: 3916354
• MDR Text Key: 4666677
• Report Number: 2221819-2014-00191
• 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: 04/11/2014

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: 04/11/2014
• Initial Date FDA Received: 05/21/2014
• 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