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

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.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, 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 Key: 5429144
• MDR Text Key: 38536140
• Report Number: 2021710-2016-03150
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 229 E
• Device Catalogue Number: 777410-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 02/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1