MAUDE Adverse Event Report: MINDRAY DS USA, INC PASSPORT 2 MONITOR; PT MONITOR

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/23/2014

Event Type  malfunction  

Event Description

Customer reported an issue with the passport 2 monitor, which may have affected pt monitoring.No pt injury was reported.

Manufacturer Narrative

Company rep evaluated the unit.Corrections included replacement of the unit's cpu board.Unit was calibrated and safety tested to factory's specifications.

• Brand Name: PASSPORT 2 MONITOR
• Type of Device: PT MONITOR
• Manufacturer (Section D): MINDRAY DS USA, INC; mahwah NJ
• Manufacturer Contact: wisara sethachutkul ; 800 macarthur blvd.; mahwah, NJ 07430 ; 2019958045
• MDR Report Key: 4037868
• MDR Text Key: 4802608
• Report Number: 2221819-2014-00445
• Device Sequence Number: 1
• Product Code: BZK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 020550
• 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: 06/24/2014

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: 06/24/2014
• Initial Date FDA Received: 08/21/2014
• 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