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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 229CE
Device Problem Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/28/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The customer¿s biomedical engineer (biomed) examined the unit and was able to confirm the reported issue. The biomed repaired the treadmill by tightening the loose power cord connection. The customer confirmed the issue was resolved after biomed repaired the unit. Due to the event being resolved by biomed tightening the loose power cord without replacing any parts; no parts will be sent back to carefusion.

 
Event Description

The customer reported while using the vmax encore device, the treadmill would power down without warning. The issue occurred during patient use; the customer reported no patient injury associated with this 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
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6277747
MDR Text Key65944969
Report Number2021710-2017-05292
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 01/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 229CE
Device Catalogue Number24-777500
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/25/2017 Patient Sequence Number: 1
Treatment
TRACKMASTER TREADMILL
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