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

Model Number 6660E-PA00012

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2022

Event Type  Death  

Manufacturer Narrative

After the report was provided, the customer stated the monitor correctly reported the spo2 value.The customer does not attribute the adverse event to the device, and there was no malfunction.

Event Description

It was reported on (b)(6) 2022 a patient was being monitored on an n1 patient monitor and spo2 readings were inaccurate.The patient expired.

• Brand Name: BENEVISION N1 PATIENT MONITOR
• Type of Device: N1 PATIENT MONITOR
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.; 1203 nanhuan ave; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer (Section G): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.; 1203 nanhuan ave; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer Contact: patrice martinez ; 800 macarthur blvd; mahwah, NJ 07430 ; 2019958026
• MDR Report Key: 15555945
• MDR Text Key: 301324886
• Report Number: 3009156722-2022-00019
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 6660E-PA00012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death