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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
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Information (3190)
Event Date 02/18/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Results of investigation: the carefusion failure analysis lab received the device and performed a failure investigation. The customer's reported issue was duplicated and it was also noted that the power supply had a burning component once turned on.

 
Event Description

The customer states that she is getting leak errors and there is a squealing noise when inhaling oxygen for nitrogen washout test. It is unknown whether there was any patient involvement. It was noted on the failure analysis that the power supply had a burning component once turned on.

 
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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 Key5676389
MDR Text Key45815147
Report Number2031702-2016-00650
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation RESPIRATORY THERAPIST
Type of Report Initial
Report Date 02/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/24/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22
Device Catalogue Number777404-101
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/13/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2016
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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