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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 22D
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 05/30/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The customer reported the suspect component is available for analysis and an return good authorization (rga) has been issued. At this time, carefusion has not received the suspect component for evaluation. If additional information becomes available, it will be submitted in a follow up report.

 
Event Description

The customer reported while using the vmax encore, a smell of smoke was noticeable while warming up the unit. The issue occurred with no patient involvement.

 
Manufacturer Narrative

The vyaire failure analysis lab received the suspected device and performed a failure investigation. The failure analysis technician confirmed burnt tracings on the analyzer control board (777348-101). The root cause is the operator error-assembly 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
kristin graf
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6661466
MDR Text Key78355340
Report Number2021710-2017-06170
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK981366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/03/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 22D
Device Catalogue Number777405-101
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 Received10/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2014
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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