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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
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 08/01/2016
Event Type  Malfunction  
Manufacturer Narrative

The carefusion identification file is (b)(4). (b)(4). At this time, carefusion has not received the suspect device/component for 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 vmax device; the customer noted a burnt smell and a smoke from the unit. The customer stated the suspect device was not being used on a patient for pulmonary function testing at the time of the event, and that it was discovered during calibrations.

 
Manufacturer Narrative

The vyaire failure analysis lab received the suspected device and performed a failure investigation. The failure analysis technician was able to confirm the burnt capacitor (c30). The root cause is the material fatigue and is an isolated incident.

 
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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
7149227830
MDR Report Key5877350
MDR Text Key52730272
Report Number2021710-2016-04236
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 10/26/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX
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 Received10/25/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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