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U.S. Department of Health and Human Services

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

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CAREFUSION CAREFUSION CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
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.

 
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Brand NameCAREFUSION
Type of DeviceCALCULATOR, 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 Key4544496
MDR Text Key5516919
Report Number2021710-2015-00284
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK981366
Number of Events Reported1
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
Date FDA Received02/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 29C
Device Catalogue Number777409-101
Was Device Available For Evaluation? Yes
Distributor Facility Aware Date01/15/2015
Device Age6 yr
Event Location Hospital
Date Manufacturer Received01/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 02/13/2015 Patient Sequence Number: 1
Treatment
FULL VISION TREADMILL, TMX428, SN: (B)(4)
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