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

Model Number 6660E-PA00012

Device Problem Device Fell (4014)

Patient Problems Head Injury (1879); Laceration(s) (1946)

Event Date 02/07/2022

Event Type  Injury  

Manufacturer Narrative

The investigation determined that the n1 was not securely seated into the mount, causing it to fall out.The hospital concluded that it was user error.

Event Description

It was reported that the benevision n1 monitor came off the wall and hit a patient, causing minor injury.

• Brand Name: BENEVISION N1 MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.; 1203 nanhuan avenue; guangming district; guangdong, shenzhen 51810 6; CH 518106
• Manufacturer (Section G): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.; 1203 nanhuan avenue; guangming district; guangdong, shenzhen 51810 6; CH 518106
• Manufacturer Contact: patrice martinez ; 800 macarthur blvd; mahwah, NJ 07430 ; 2019958026
• MDR Report Key: 13907641
• MDR Text Key: 289894987
• Report Number: 3009156722-2022-00006
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/07/2022

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: 02/07/2022
• Initial Date FDA Received: 03/25/2022
• 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
• Patient Outcome(s): Other