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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION VMAX CAREFUSION VMAX ENCORE 229C PULMONARY FUNCTION TESTING SYSTEM

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CAREFUSION VMAX CAREFUSION VMAX ENCORE 229C PULMONARY FUNCTION TESTING SYSTEM Back to Search Results
Model Number ENCORE 229C
Device Problem Incorrect Measurement (1383)
Patient Problem No Patient Involvement (2645)
Event Date 07/20/2015
Event Type  Malfunction  
Event Description

Carefusion vmax encore 229c pulmonary function testing system not measuring lung volumes accurately via nitrogen washout method. In (b)(6) of this year, routine quality assurance of pulmonary function testing systems revealed inconsistent results for the measurement of functional residual capacity. Carefusion technical support was contacted and onsite service was dispatched to investigate the issue. Carefusion recognized the discrepancy and replaced the encore 229c module 4 times in order to correct the problem. Carefusion cannot provide any explanation why this is occurring. To date the latest replacement 229c module still has a discrepancy with an error in measurement up to 30 percent. No patient involved. Testing patients was avoided to due to equipment inaccuracy.

 
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Brand NameCAREFUSION VMAX ENCORE 229C
Type of DevicePULMONARY FUNCTION TESTING SYSTEM
Manufacturer (Section D)
CAREFUSION VMAX
yorba linda CA 92887
MDR Report Key5161768
MDR Text Key28846143
Report NumberMW5057204
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberENCORE 229C
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/09/2015 Patient Sequence Number: 1
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