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

Model Number VMAX

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

The carefusion identification file is (b)(4).(b)(4).At this time, carefusion has not received the suspect device/component for evaluation.Upon completion of a final evaluation, a supplemental report will be submitted.

Event Description

The customer reported while using the static and dynamic compliance vmax device; the customer noted a burnt smell and a smoke from the unit.The customer stated the suspect device was not being used on a patient for pulmonary function testing at the time of the event, and that it was discovered during calibrations.

Manufacturer Narrative

The vyaire failure analysis lab received the suspected device and performed a failure investigation.The failure analysis technician was able to confirm the burnt capacitor (c30).The root cause is the material fatigue and is an isolated incident.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5877350
• MDR Text Key: 52730272
• Report Number: 2021710-2016-04236
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

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: VMAX
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/15/2016
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2006
• 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