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

Model Number N1, NELLCOR, ST, GLASGOW

Device Problem Mechanical Problem (1384)

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

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

The investigation determined that the n1 was not securely seated (latched on) into the mount, causing it to fall out.The hospital concluded that it was a user error.Mindray field service evaluated the benevision n1 and the locking mechanism and no issues were identified.The benevision n1 patient monitor operator's manual provides instructions on ensuring that an n1 is correctly latched in the dock and cannot be pulled out.The user must firmly push the n1 until an audible click is heard, indicating that the clip engaged the dock.

Event Description

It was reported that on september 13, 2023, at 9:30 am an benevision n1 patient monitor (serial number (b)(6)) had fallen off its dock and struck a patient's head.The patient suffered a laceration upon impact.A ct scan was performed on the patient, and the scan came back normal.

• Brand Name: BENEVISION N1 PATIENT MONITOR
• Type of Device: N1
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer (Section G): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer Contact: sonia vale ; 800 macarthur blvd.; mahwah, NJ
• MDR Report Key: 17897460
• MDR Text Key: 325245712
• Report Number: 3009156722-2023-00003
• 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: Physician
• Type of Report: Initial
• Report Date: 09/13/2023

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: N1, NELLCOR, ST, GLASGOW
• Device Catalogue Number: 6660E-PA00012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female