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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINDRAY NORTH AMERICA MINDRAY ANESTHESIA MACHINE

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MINDRAY NORTH AMERICA MINDRAY ANESTHESIA MACHINE Back to Search Results
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.
 
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Brand NameMINDRAY
Type of DeviceANESTHESIA MACHINE
Manufacturer (Section D)
MINDRAY NORTH AMERICA
mahwah NJ 07430
MDR Report Key6421850
MDR Text Key70820512
Report Number6421850
Device Sequence Number1
Product Code BSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received03/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA7
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/30/2016
Event Location Hospital
Date Report to Manufacturer12/30/2016
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/21/2017 Patient Sequence Number: 1
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