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

Model Number VMAX ENCORE 229

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time, carefusion has not received the suspect device/component for evaluation but a carefusion field service engineer (fse) has been dispatched to perform an onsite 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; the treadmill stops within different protocols without warning.The issue occurred during patient use; the customer reported no patient injury associated with this event.

Manufacturer Narrative

The carefusion field service engineer (fse) on site performed testing and confirmed the reported issue.The fse re-installed the cardiosoft v6.51 software and the customer performed calibration.The unit is meeting carefusion specifications.Due to the event being resolved by re-installing the software; no parts will be sent back to carefusion.

• 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: 5777562
• MDR Text Key: 49021445
• Report Number: 2021710-2016-04029
• 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: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VMAX ENCORE 229
• Device Catalogue Number: 777400-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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