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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 22 E
Device Problems Charred (1086); Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Date 04/21/2015
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 mdr's following the issuance of a 483. The carefusion identification file is (b)(4). The device was evaluated by a carefusion factory service technician and the reported issue was duplicated. It was unable to perform a dlco calibration test. Also, he noticed that a burning smell was coming from the analyzer control board and the part was sent to the failure analysis lab for further investigation. If more information becomes available a follow up will be submitted. A replacement module was sent to the customer and installed successfully by a fse. Carefusion continues to track and trend any incident related to this issue. (b)(4).

 
Event Description

The customer reported getting a multi-gas sensor calibration out of range warning during a lung diffusion carbon monoxide (dlco) gas calibration and was unable to test patients. A carefusion field service engineer (fse) went on-site to repair the device and while replacing the sample pump he noticed a charring of the analyzer control board and a burning smell coming from the module. The device was returned to carefusion for an evaluation. There was no patient involvement.

 
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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 Key5428610
MDR Text Key38477215
Report Number2021710-2016-03149
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 04/21/2015
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 Number22 E
Device Catalogue Number777404-101
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/08/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2015
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

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