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U.S. Department of Health and Human Services

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

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CAREFUSION, INC STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number VMAX ENCORE
Device Problem Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 03/10/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The carefusion field service engineer (fse) went on site to evaluate the device. The fse duplicated the issue and found that the protocols were set incorrectly. He reset the treadmill to external treadmill instead of papr protocol and now the speed and grade are transferring over to the vmax correctly.

 
Event Description

The customer reported while using the vmax encore device, the treadmill would stop during use. There was no person placed on the treadmill for the simulated test.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
Type of DeviceCALCULATOR, 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
kristin graf
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6453846
MDR Text Key71710734
Report Number2021710-2017-05700
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK942211
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE
Device Catalogue Number777401-101
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/03/2017 Patient Sequence Number: 1
Treatment
TRACKMASTER TREADMILL
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