MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. MINDRAY PASSPORT 17M PATIENT MONITOR

Device Problem No Audible Alarm (1019)

Patient Problem Arrhythmia (1721)

Event Date 01/28/2022

Event Type  Death  

Event Description

It was reported that on (b)(6) 2022, at 17:49 pm, the spo2 level dropped to 40 on a patient monitored in icu room 4.Both "low spo2" and "spo2 desat" alarms occurred at the central station but there was no alarm noted at the passport 17m monitor.It was reported that the patient expired.

Manufacturer Narrative

An investigation was performed using the system logs and a functional evaluation of the monitor.The investigation confirms that the passport 17m monitor generated audible alarms for "low spo2" and "spo2 desat".

• Brand Name: MINDRAY PASSPORT 17M PATIENT MONITOR
• Type of Device: PASSPORT 17M
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.; 1203 nanhuan avenue; guangming district; guangdong, shenzhen 51810 6; CH 518106
• MDR Report Key: 13891969
• MDR Text Key: 287839309
• Report Number: 2221819-2022-00005
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Report to Manufacturer: 02/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death