MAUDE Adverse Event Report: CAREFUSION CAREFUSION; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number VMAX ENCORE 29C

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

The following descriptions of the event were documented by a carefusion technical support specialist in response to phone conversations with a user facility representative and a carefusion field service representative."called with questions about exercise test.She mentioned something about test defaulting to cardio.They currently use tmill but had a bike installed recently but not used it yet.I asked her to explain what was going on, she said she was going to put the doctor on the phone.She said someone from carefusion was supposed to visit them today but she did not provide a name.She had another call from someone else from carefusion so she ended the call with me.Asked her to let us know if she needed further assistance.Still not sure who was coming onsite today or who called her." "[name removed] onsite.Issue with new treadmill tmx 428 (b)(4) that was installed.They report that on a test earlier today that the tmill had sped up in the early part of exercise phase.Went from 1.3 mph to 2.7 mph.Doctor noticed that pt was moving at a pace quicker than what he should be at that phase in the test.Bruce protocol.[name removed] will print up tabular test info for this test showing the increase in speed.Asked him to also print up protocol settings in cardiosoft 6.71 as well as general settings.He will forward info to me.".

Manufacturer Narrative

(b)(4).Based on the input from the field service representative as well as consultation with an exercise physiology subject matter expert, the issue appears to be operator training related and not related to any inherent malfunction of the treadmill itself.

• Brand Name: CAREFUSION
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: james style ; 7608837120
• MDR Report Key: 4544496
• MDR Text Key: 5516919
• Report Number: 2021710-2015-00284
• 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: User Facility,Company Representative
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VMAX ENCORE 29C
• Device Catalogue Number: 777409-101
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/15/2015
• Device Age: 6 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FULL VISION TREADMILL, TMX428, SN: (B)(4)