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

Model Number A5

Device Problem Gas/Air Leak (2946)

Patient Problem No Code Available (3191)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

The a5 anesthesia system unit in operating room 1 and other a5 anesthesia system units were tested on the site by mindray's field service representative, the units and vaporizers passed all leak and functional tests per specifications.No leaks or other malfunction were identified however the a5 anesthesia systems in operating room 1 and operating room 4 were found to have the scavenger valve turned off.The investigation findings and the logs of the four a5 anesthesia system units were collected and sent to the manufacturer for further evaluation.The manufacturer did not identify any anomaly in the logs and concluded that due to the scavenger valve being turned off during use in operating room 1, waste gas was emitted into the operating room on the day of the reported event.The operating manual instructs the user to inspect the scavenger system prior to use, therefore, the lack of the preoperative tests appear to have contributed to the reported event.(b)(4).

Event Description

The customer reported the evacuation of their facility due to a gas leak.Subsequently, they reported that the gas leak was "suspected" to come from the a5 anesthesia system.A total of 19 people/staff received treatment, 12 were sent to different hospitals.The people/staff involved recovered on the same day, no life threatening illness or other adverse events were reported.During the evacuation, a patient was undergoing a procedure in operating room 1 where anesthesia was being delivered by the a5 system, no patient injury or other adverse event were reported resulting from this event.

• Brand Name: A5 ANESTHESIA SYSTEM
• Type of Device: ANESTHESIA SYSTEM, PRODUCT CODE: BSZ
• 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 51810-8 ; CH 518108
• MDR Report Key: 6857421
• MDR Text Key: 85853918
• Report Number: 3007222337-2017-00019
• 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,consum
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/11/2017,08/12/2017

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: A5
• Device Catalogue Number: 0631F-01000-06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2017
• Initial Date Manufacturer Received: 08/12/2017
• Initial Date FDA Received: 09/12/2017
• 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): Hospitalization