MAUDE Adverse Event Report: CAREFUSION VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number 229C E

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

The carefusion file identification number is (b)(4).At this time the device is functioning as intended and is in normal operation.Carefusion continues to track and trend any incident related to this issue.(b)(4).

Event Description

It was reported by the customer that while doing a test the treadmill abruptly stopped.It went from a speed of 2 miles per hour and a grade of 10.5 to zero.There was no patient harm or injury reported.A carefusion field service technician (fst) inspected the treadmill and all of its connections and ran a test protocol study without issue.All factors and settings were found to be within specifications.It was determined that there were network issues at the facility which caused the loss of communication between the device and the treadmill.

• Brand Name: VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5212810
• MDR Text Key: 31016989
• Report Number: 2021710-2015-02172
• 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: Respiratory Therapist
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 229C E
• Device Catalogue Number: 777410-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• 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 Age: 68 YR
• Patient Weight: 81