MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD PASSPORT 2 MONITOR; PASSPORT 2 PATIENT MONITOR

Catalog Number 0998-00-0900-5014A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Sudden Cardiac Death (2510)

Event Date 02/21/2020

Event Type  Death  

Manufacturer Narrative

The user facility requested an evaluation of the equipment; no malfunction of the equipment was claimed.The results of the evaluation determined the monitor alarm volume was set to its minimum level.It was also observed that the heart rate numerics were displayed with a four second delay, however, high and low heart rate alarms were confirmed to have been called visually and audibly.Movement of the esis trunk cable caused ecg waveform artifact resulting in the delay of the heart rate numerics.The cable was replaced and there was no further delay with the display of heart rate numerics.

Event Description

It was reported that a patient monitored on a passport 2 monitor and gas module was having surgery and one minute into the procedure the patient's heart stopped; the patient later expired.

• Brand Name: PASSPORT 2 MONITOR
• Type of Device: PASSPORT 2 PATIENT MONITOR
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; buildings 9-13 baiwangxin; high-tech industrial park; baimang, xili town, nanshan, shenzen 51810 8; CH 518108
• Manufacturer (Section G): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; buildings 9-13 baiwangxin; high-tech industrial park; baimang, xili town, nanshan, shenzen 51810 8; CH 518108
• Manufacturer Contact: serena chen ; 1203 nanhuan avenue; guangming district; shenzhen, shenzhen 51810-6 ; CH 518106
• MDR Report Key: 9885701
• MDR Text Key: 185129536
• Report Number: 3009156722-2020-00005
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0900-5014A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 7 YR