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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 229
Device Problem Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 08/25/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Carefusion field service representative (fsr) was dispatched to perform an onsite evaluation. The fsr performed a firmware upgrade on the treadmill to 0. 4f. The fsr then performed an operation check and ran a custom protocol in order to verify the functionality of the treadmill. The testing was run five times and the reported issue was resolved. The treadmill is meeting all manufacture specifications no device or parts will be returned at this time.

 
Event Description

The customer reported that while using the static and dynamic compliance, the track master treadmill tmx428cp stopped in the middle of a test. The customer reported seeing a ¿tether error¿ message. The reported issue occurred during preparation for use and there was no patient involvement.

 
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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 drive
palm springs CA 92262
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
7149227830
MDR Report Key5956492
MDR Text Key55259963
Report Number2021710-2016-04453
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 08/25/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 229
Device Catalogue Number777400-101
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 Received08/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2015
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: 09/16/2016 Patient Sequence Number: 1
Treatment
TRACKMASTER TREADMILL TMX428CP
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