MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. PASSPORT 12 PATIENT MONITOR; PASSORT 12 PATIENT MONITOR

Model Number 6105F-PA00001

Device Problem No Apparent Adverse Event (3189)

Patient Problem Arrhythmia (1721)

Event Date 03/04/2022

Event Type  Death  

Manufacturer Narrative

No malfunction was alleged, the customer did not attribute the patient event to the devices but requested review of the system logs.Upon review, the systems were confirmed to have operated to specification.

Event Description

A patient expired prior to the initiation of a medical procedure.At the time, the patient was being monitored on the passport 12 monitor in use with the a3 anesthesia delivery system.The customer notified mindray and requested a review of system logs, no malfunction was alleged.The patient event was not attributed to the devices.

• Brand Name: PASSPORT 12 PATIENT MONITOR
• Type of Device: PASSORT 12 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: 14188198
• MDR Text Key: 289888389
• Report Number: 3009156722-2022-00008
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2022

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: 6105F-PA00001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 04/22/2022
• 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): Death