MAUDE Adverse Event Report: CAREFUSION, INC STATIC AND DYNAMIC COMPLIANCE; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number 22 E

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Information (3190)

Event Date 01/17/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results of investigation: the carefusion failure analysis lab received the suspected component and performed a failure investigation.The reported issue was a burnt mass flow sensor board in the laboratory setting.The root cause of the reported issue was found to be a burnt capacitor, c35, on the board.If additional information becomes available, it will be submitted in a follow up report.

Event Description

The customer reported her vmax encore 22e module is no longer working.During testing she got a warning that the software is incompatible and could smell something burning.It is unknown if there was any patient involvement.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION, INC; 1100 bird center drive; palm springs CA 92262
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6051788
• MDR Text Key: 58356498
• Report Number: 2031702-2016-01176
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/24/2016

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: 22 E
• Device Catalogue Number: 24-777494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1