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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINDRAY USA DS, INC AS3000 ANESTHESIA DELIVERY SYSTEM
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MINDRAY USA DS, INC AS3000 ANESTHESIA DELIVERY SYSTEM Back to Search Results
Device Problems No Device Output (1435); Delivery System Failure (2905)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/14/2014
Event Type  malfunction  
Event Description
Customer reported the as3000 anesthesia delivery system froze and failed to ventilate a pt.The clinician extubated the pt and reported the pt could not be manually ventilated.Customer requested the company service rep to eval the system.No pt injury was reported.
 
Manufacturer Narrative
Company rep evaluated the system and could not reproduce the reported problem.As a preventative maintenance, the following parts were replaced; cpu board, power supply, and two pcb's in the user interface assembly.System was calibrated and tested to factory's specs.
 
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Brand Name
AS3000 ANESTHESIA DELIVERY SYSTEM
Type of Device
ANESTHESIA DELIVERY SYSTEM
Manufacturer (Section D)
MINDRAY USA DS, INC
mahwah NJ
Manufacturer Contact
wisara sethachutkul
800 macarthur blvd.
mahwah, NJ 07430
2019958045
MDR Report Key3918134
MDR Text Key15819065
Report Number2221819-2014-00225
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
080175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2014
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 Unknown
Patient Sequence Number1
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