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

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.

• Brand Name: CAREFUSION VMAX ENCORE 229C
• Type of Device: PULMONARY FUNCTION TESTING SYSTEM
• Manufacturer (Section D): CAREFUSION VMAX; yorba linda CA 92887
• MDR Report Key: 5161768
• MDR Text Key: 28846143
• Report Number: MW5057204
• Device Sequence Number: 1
• Product Code: BTY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENCORE 229C
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other