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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 29 UNIT ASSEMBLY
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). No device or parts will not be returned to carefusion for evaluation at this time as the reported issue seems to be due to a software upgrade. The customer performed the software upgrade and the reported issue was resolved.

 
Event Description

The customer reported that the treadmill has been stopping during testing while in use on a patient and using the cardio v6. 51 cam14 with usb.

 
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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 Key6028289
MDR Text Key57397600
Report Number2021710-2016-04637
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 09/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 29 UNIT ASSEMBLY
Device Catalogue Number777497
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 Received09/20/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/02/2009
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: 10/13/2016 Patient Sequence Number: 1
Treatment
CARDIO V6.51 CAM14 W/USB, (B)(4)
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