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

Model Number VMAX ENCORE 29 UNIT ASSEM

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No device or parts will not be returned to carefusion for evaluation.The customer reran the protocol and the reported issue was not observed so the customer has stated they only want to document the issue and will not be returning the device for evaluation.

Event Description

The customer reported that trackmaster treadmill stopped fourteen minutes into the exercise phase using the modified mvo2 protocol.The device was in use on a patient at the time of the event; however, there was no injury to the patient.The customer later ran a mock test using the same protocol and the treadmill did not stop.

• 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: 6097717
• MDR Text Key: 60083620
• Report Number: 2021710-2016-04833
• 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
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VMAX ENCORE 29 UNIT ASSEM
• Device Catalogue Number: 229C E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2010
• 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: TRKMSTR TRDMILL DOM 220V NO CNTRL, SN: (B)(4)
• Patient Outcome(s): Other