MAUDE Adverse Event Report: MINDRAY DS USA INC V SERIES MONITOR; PATIENT MONITOR

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Type  malfunction  

Event Description

Customer reported v series monitor came off vdock and fell.This took place shortly after the monitor had been moved from one vdock to another.No patient injury was reported.

Manufacturer Narrative

The customer also requested training on proper docking at the time.Mindray service rep evaluated monitor and dock on site and found no visible evidence of defect in dock latching mechanisms.Device is being shipped to mindray national repair ctr for further eval.

• Brand Name: V SERIES MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): MINDRAY DS USA INC; mahwah NJ
• Manufacturer Contact: wisara sethachutkul ; 800 macarthur blvd.; mahwah, NJ 07430 ; 2019558045
• MDR Report Key: 4037792
• MDR Text Key: 17696832
• Report Number: 2221819-2014-00503
• Device Sequence Number: 1
• Product Code: BZK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 102004
• 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: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• 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
• Date Manufacturer Received: 07/18/2014
• 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