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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 10/28/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). At this time, carefusion has not received the suspect device/component for evaluation. The customer has reported that the device was checked out by a technician and the reported issue could not be duplicated. The customer considers the issue resolved and no further evaluation or return of the device is expected. Should additional information become available a supplemental report will be submitted.

 
Event Description

The customer reported that while using the static and dynamic compliance, the track master treadmill (b)(4) stopped during patient use. The incident occurred twice in one study. The customer reported that there was no patient harm or injury.

 
Manufacturer Narrative

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, resulted in a computer error. 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.

 
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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
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6125913
MDR Text Key61094402
Report Number2021710-2016-04933
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,Followup,Followup
Report Date 03/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/23/2016
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 Number777404-101
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 Received03/16/2017
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: 11/23/2016 Patient Sequence Number: 1
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