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

Model Number VMAX ENCORE 22

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At this time, carefusion has not received the suspect device/component for evaluation.The customer has reported that the device was checked out by a technician and the reported issue could not be duplicated.The customer considers the issue resolved and no further evaluation or return of the device is expected.Should additional information become available a supplemental report will be submitted.

Event Description

The customer reported that while using the static and dynamic compliance, the track master treadmill (b)(4) stopped during patient use.The incident occurred twice in one study.The customer reported that there was no patient harm or injury.

Manufacturer Narrative

A vyaire field service representative (fsr) was dispatched to evaluate the system.The fsr was unable to duplicate the reported problem.After review of computer logs, it was determined anti-virus software scanned during patient testing, resulted in a computer error.The customer was provided information regarding the use of the product and anti-virus software scanning and that scanning must be disabled during patient testing.

• 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
• MDR Report Key: 6125913
• MDR Text Key: 61094402
• Report Number: 2021710-2016-04933
• 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: Respiratory Therapist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VMAX ENCORE 22
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2003
• 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
• Patient Outcome(s): Other