MAUDE Adverse Event Report: CAREFUSION CAREFUSION; CALCULATOR, PERDICTED VALUES, PULMONARY FUNCTION/B

Model Number VMAX ENCORE 29C

Device Problems Computer Operating System Problem (2898); Device Operational Issue (2914)

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

Event Date 12/17/2014

Event Type  malfunction  

Event Description

The following info concerning the event was documented by carefusion rep(s) in response to phone conversation(s) with a carefusion clinical operations mgr and user facility rep(s)."[name removed] called in states the account is complaining the tm speeds ups and runs to fast said they talked to someone in tech support??? [name removed] has checked the protocols the are fine [name removed] states he did not see this happen"."spoke to dr.Says he thinks it is a peds tm tm 425c sn (b)(4) says this is an older tm not the sn in our database maybe the itm needs a firmware upgrade using mph and not kpm sees tm speed as doubled kids have almost been thrown off dr states if this happen once more he is going to close the lab down says this happened after the win7 upgrade"."the customer advocate mgr had a phone conversation with [name removed] the nurse mgr at the user facility regarding the treadmill issue.Neither patient (despite being in a compromised cardiovascular and/or pulmonary state) was harmed at the time the ramp-up occurred.No medical intervention was required at the time.The patients were both assisted off of the treadmill and allowed to rest.According to [name removed] neither has been treated for any other adverse event related to the situation; however, the belief is that should this recur it has the potential to cause harm (risk for serious injury or death)".

Manufacturer Narrative

Carefusion submitted medwatch report #2021710-2015-00005 on (b)(4) 2015 regarding the first patient event mentioned.This medwatch report concerns the second patient event that carefusion became aware of on (b)(4) 2014.The user facility did not submit a user facility report to the mfr.Event codes were derived based on info provided by the user facility rep(s).(b)(4).The following info concerning the evaluation of the device is a summary of the info documented by the carefusion field service rep.The carefusion field service rep evaluated the device and in consultation with a carefusion tech support rep determined that the most likely cause of the reported event was an issue with the model: tmx425c treadmill, sn: fv-(b)(4) manufactured by full vision inc.The carefusion field service rep advised the user facility to contact full vision inc.And have them come in and evaluate the treadmill.Carefusion contacted full vision inc.And they confirmed that the tmx425c treadmill, sn: fv-(b)(4) was manufactured on 12/31/2001.They further stated that this product that is no longer manufactured by them though it is still being serviced by them and is not yet obsolete.The full vision rep indicated that an intermittent interface cable can cause speed changes and recommended that the user facility have the treadmill calibrated.For customer satisfaction, carefusion has shipped the user facility a new treadmill and recommended that they take the old treadmill out of service.

• Brand Name: CAREFUSION
• Type of Device: CALCULATOR, PERDICTED VALUES, PULMONARY FUNCTION/B
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer Contact: james stytle ; 1100 bird center dr.; palm springs, CA 92262 ; 7608837120
• MDR Report Key: 4438114
• MDR Text Key: 5394783
• Report Number: 2021710-2015-00081
• 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: Other
• Type of Report: Initial
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/17/2014
• Device Age: 6 YR
• Event Location: Hospital
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CAREFUSION ECGC, SN: (B)(4),; FULL VISION TREADMILL, MODEL: TMX425C, SN: (B)(4)