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

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/08/2016

Event Type  malfunction  

Event Description

Oxygen sensor not working correctly resulting in erroneous results.Three patients needed to be retested.No patient harm.

• Brand Name: VMAX
• 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: 6056949
• MDR Text Key: 58381152
• Report Number: 6056949
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 51