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

Model Number VMAX ENCORE

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The carefusion technical support assisted the customer with performing firmware upgrade which solved the stopping issue.Due to the event being resolved by upgrading the firmware; no parts will be sent back to carefusion.

Event Description

The customer reported while using the vmax encore device, the treadmill would stop during use.The issue occurred during patient use but no patient injury was reported.

• 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: 6340693
• MDR Text Key: 68014750
• Report Number: 2021710-2017-05437
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942211
• 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
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VMAX ENCORE
• Device Catalogue Number: 777401-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Date Device Manufactured: 09/01/2011
• 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
• Treatment: TRACKMASTER TREADMILL
• Patient Outcome(s): Other