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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 22
Device Problem Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). A vyaire field service representative (fsr) was dispatched to evaluate the system. The fsr was unable to duplicate the reported problem. After review of computer logs, it was determined anti-virus software scanned during patient testing, then a computer error occurred. The customer was provided information regarding the use of the product and anti-virus software scanning and that scanning must be disabled during patient testing.

 
Event Description

The customer reported that while using the static and dynamic compliance, the track master treadmill dom 220v stopped while performing a vo2/exercise study on a patient. The customer reported that there was no patient harm or injury associated with the event.

 
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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 Key6408371
MDR Text Key70305546
Report Number2021710-2017-05601
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation RESPIRATORY THERAPIST
Type of Report Initial
Report Date 03/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 22
Device Catalogue NumberPS-777404-101
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 Received12/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2003
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: 03/15/2017 Patient Sequence Number: 1
Treatment
TRACKMASTER TREADMILL
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