MAUDE Adverse Event Report: CAREFUSION 207, INC DBA CAREFUSION VMAX ENCORE; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2014

Event Type  malfunction  

Event Description

There was a drift in average correction factors on the pulmonary function testing (pft) machine; resulting in the possibilities of unreliable results.It was discovered that there was a leak in a tube.
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manufacturer response for pft machine and bodybox, carefusion vmax pft machine (per site reporter)
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carefusion tech serviceman came and discovered the leak in a tube and corrected the problem and serviced it.Also evaluated the pft machine for any further issues.There were none.Service tech suggested ways to recheck for leaks.

• Brand Name: VMAX ENCORE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION 207, INC DBA CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• MDR Report Key: 4324692
• MDR Text Key: 17692269
• Report Number: 4324692
• Device Sequence Number: 1
• Product Code: BTY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 12/09/2014

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: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1