MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD A5 ANESTHESIA SYSTEM

Model Number A5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Failure (2484)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

The customer clarified that no malfunction occurred during the "code blue" events.The request for the device evaluation was a precautionary measure of the facility.The a5 anesthesia system was evaluated and performed to specifications and was returned to the service.Additional information related to the events and to the patients was requested, however, the requested information is not provided by the facility.(b)(4).

Event Description

The customer requested to evaluate an a5 anesthesia system because during two (2) surgical cases, on the same day, two (2) different patients were announced "code blue".No alleged malfunction of the unit was reported.Emdr# 2221819-2017-00015 is documenting the event with the first patient.

• Brand Name: A5 ANESTHESIA SYSTEM
• Type of Device: ANESTHESIA SYSTEM
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; buildings 9-13, baiwangxin; high-tech industrial park; baimang, xili town, nanshan, 51810 8; CH 518108
• Manufacturer Contact: serena chen ; buildings 9-13, baiwangxin; high-tech industrial park; baimang, xili town, nanshan, shenzhen 51810-8 ; CH 518108
• MDR Report Key: 6644636
• MDR Text Key: 77700973
• Report Number: 3007222337-2017-00016
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/13/2017,05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: A5
• Device Catalogue Number: 0631F-01000-06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/16/2017
• Date Report to Manufacturer: 06/13/2017
• Date Manufacturer Received: 05/16/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening