MAUDE Adverse Event Report: MINDRAY NORTH AMERICA MINDRAY; ANESTHESIA MACHINE

Model Number A7

Device Problems Defective Alarm (1014); Device Operates Differently Than Expected (2913); Gas/Air Leak (2946)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/30/2016

Event Type  malfunction  

Event Description

Machine malfunction caused patient to code.Reported that the machine had an excessive leak in the ventilator portion of the machine.During this time oxygen was not getting to the patient.Staff cannot recall any alarms indicating a leak in the ventilator portion of the system.It was reported that the leak could be heard by the anesthesia tech near the gauge portion of the ventilator.Tech pushed down on the gauge and reinstalled it back into the machine fixing the leak issue.Until that moment the staff, anesthesia tech, and biomed department did not know this gauge was removable.Gauge sits in a circular hold with an o-ring that prevents any leakage.The anesthesia machine was checked out and was run through the mfr tests before the case sometime in the morning.Machine checked good per mfr specifications.Sometime between the initial testing of the machine and when the case started the gauge had popped out of the ventilator portion of the assembly causing the excessive leak.Why the machine didn't alarm and notify the physician is unk at this time.Service rep came out the same day and replaced the gauge, which was reported as being faulty.Mindray took the gauge and will conduct their own testing on the gauge and the failure.It was also reported that this same incident happens a few days early but no harm to the patient reported.This is word of mouth and cannot be verified at this time.Anesthesia machines were installed in (b)(6) 2016 and incoming inspections conducted by a qualified mindray field service rep.

• Brand Name: MINDRAY
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): MINDRAY NORTH AMERICA; mahwah NJ 07430
• MDR Report Key: 6421850
• MDR Text Key: 70820512
• Report Number: 6421850
• Device Sequence Number: 1
• Product Code: BSZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 94