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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 229 E
Device Problems Overheating of Device (1437); Smoking (1585)
Patient Problem Red Eye(s) (2038)
Event Date 09/22/2014
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 malfunctioning computer was retired from service and the user facility information technology specialist will remove the old hard drive to destroy it and then the computer will be discarded under the user facility's supervision. The customer purchased an upgraded computer and it has been installed and is functioning as intended per the operator's manual. If additional 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 a smell which he describes as hot like something within the computer is melting. Also, the display has become pixilated and the software is not responding appropriately during both functional residual capacity (frc) testing and lung diffusion capacity (dlco) testing. When the system is on for a length of time the odor is more noticeable and the staff noted that the room is hazy. Carefusion technical support technician recommended to turn off the computer immediately and unplug it from it's power source as it could pose a fire risk. The customer reported an irritation to the eyes while in the room but no medical attention was sought. The device will not be returning to carefusion for an evaluation.

 
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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 Key5429144
MDR Text Key38536140
Report Number2021710-2016-03150
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
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 09/22/2014
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 Number229 E
Device Catalogue Number777410-101
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 Received09/22/2014
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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