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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

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CAREFUSION STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number 22D E
Device Problems Sparking (2595); Environmental Particulates (2930)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2013
Event Type  Malfunction  
Manufacturer Narrative

This mdr is being submitted in response to a two year retrospective complaint review that was performed by carefusion to identify mdrs following the issuance of a 483. The (b)(4) the device was not returned so no investigation could be done and no root cause could be determined. The device is currently working without issue. If more information becomes available a follow up will be submitted. Carefusion continues to track and trend any incident related to this issue. (b)(4).

 
Event Description

The customer reported the isolation transformer started to spark and smell like smoke as if the system was burning. The system was not used after the reported incident. The customer's biomed took a look at the device and determined that the sparking was coming from the wall outlet and not associated with the pulmonary function testing (pft) system. The customer is now using the device without any issues. There was no harm or injury noted.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
Type of DeviceCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Manufacturer (Section D)
CAREFUSION
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
CAREFUSION
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
jill rittorno
75 north fairway drive
vernon hills, IL 60061
8473628056
MDR Report Key5429096
MDR Text Key38490362
Report Number2021710-2016-03158
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 07/01/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/10/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22D E
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 Received07/01/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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