MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION CENTRAL MONITORING SYSTEM

Model Number BENEVISION CENTRAL MONITORING SYSTEM

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6) service representative visited the site and collected error lost from multiple systems.An evaluation is underway, however, it noted that the site is unable to provide specific information about the system involved or other evidence of the event such as ecg strips.Source of the report: mw5077371.(b)(4).

Event Description

Customer reported that patient began having pauses of less than 2 seconds.First pause at 16.50- alarm did not sound, rhythm strip did print with occurrence.Second pause at 17.27- alarm did not sound and rhythm strip did not print with occurrence.No patient injury was reported.

• Brand Name: BENEVISION CENTRAL MONITORING SYSTEM
• Type of Device: BENEVISION
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue guangming; guangming district; shenzhen, guangdong 51810 6; CH 518106
• Manufacturer Contact: serena chen ; keji 12th road south; hi-tech industrial park; shenzhen, nanshan 51805-7 ; CH 518057
• MDR Report Key: 7622659
• MDR Text Key: 112315753
• Report Number: 3009156722-2018-00008
• Device Sequence Number: 1
• Product Code: MSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/21/2018,05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BENEVISION CENTRAL MONITORING SYSTEM
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2018
• Distributor Facility Aware Date: 05/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2018
• Date Manufacturer Received: 05/29/2018
• 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: Reuse
• Patient Sequence Number: 1