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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 22 E
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Information (3190)
Event Date 01/17/2013
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Results of investigation: the carefusion failure analysis lab received the suspected component and performed a failure investigation. The reported issue was a burnt mass flow sensor board in the laboratory setting. The root cause of the reported issue was found to be a burnt capacitor, c35, on the board. If additional information becomes available, it will be submitted in a follow up report.

 
Event Description

The customer reported her vmax encore 22e module is no longer working. During testing she got a warning that the software is incompatible and could smell something burning. It is unknown if there was any patient involvement.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
Type of DeviceCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Manufacturer (Section D)
CAREFUSION, INC
1100 bird center drive
palm springs CA 92262
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
MDR Report Key6051788
MDR Text Key58356498
Report Number2031702-2016-01176
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 HEALTH PROFESSIONAL
Type of Report Initial
Report Date 10/24/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Device Catalogue Number24-777494
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/31/2013
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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