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

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.

• 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: 5428610
• MDR Text Key: 38477215
• Report Number: 2021710-2016-03149
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22 E
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• 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: N
• Patient Sequence Number: 1