• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Consequences Or Impact To Patient (2199)
Event Date 06/16/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). At this time, carefusion has not received the suspect device/component for evaluation but a carefusion field service engineer (fse) has been dispatched to perform an onsite evaluation. Upon completion of a final evaluation, a supplemental report will be submitted.

 
Event Description

The customer reported while using the static and dynamic compliance; the treadmill stops within different protocols without warning. The issue occurred during patient use; the customer reported no patient injury associated with this event.

 
Manufacturer Narrative

The carefusion field service engineer (fse) on site performed testing and confirmed the reported issue. The fse re-installed the cardiosoft v6. 51 software and the customer performed calibration. The unit is meeting carefusion specifications. Due to the event being resolved by re-installing the software; no parts will be sent back to carefusion.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
7149227830
MDR Report Key5777562
MDR Text Key49021445
Report Number2021710-2016-04029
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2016
Is This An Adverse Event Report? Yes
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 Received07/09/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2011
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: 07/07/2016 Patient Sequence Number: 1
-
-