MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION N1 PATIENT MONITOR

Model Number 6660EPA00018

Device Problem Increase in Pressure (1491)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

An investigation is in process.

Event Description

It was reported that while taking a blood pressure reading, the non-invasive blood pressure cuff used on the benevision n1 patient monitor over inflated causing the patient pain and petechiae.

Manufacturer Narrative

A full functional evaluation of the device was performed with no malfunction observed.The customer reported using a blood pressure cuff that is not approved for use with mindray's patient monitor products, which likely resulted in the reported over inflation of the cuff.

Event Description

It was reported that while taking a blood pressure reading, the non-invasive blod pressure cuff used on the benevision n1 patient monitor over inflated causing the patient pain and petechiae.

• Brand Name: BENEVISION N1 PATIENT MONITOR
• Type of Device: N1 PATIENT MONITOR
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guandong 51810 6; CH 518106
• MDR Report Key: 10905094
• MDR Text Key: 230323985
• Report Number: 3009156722-2020-00011
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K192972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6660EPA00018
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other