MAUDE Adverse Event Report: CAREFUSION OXYCON PRO; CALCULATOR, PULMONARY FUNCTION DATA

Model Number OXYCON PRO

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.At this time the device is functioning as intended and is in normal operation.Should additional information become available a supplemental report will be submitted.Carefusion continues to track and trend any incident related to this issue.(b)(4).

Event Description

The customer reported that while doing a test the treadmill unexpectedly stopped.There was no patient harm or injury reported.A carefusion field service technician (fst) inspected the treadmill and all of its connections and ran a test protocol study without issue.All factors and settings were found to be within specifications.It was determined that the treadmill time out had to extended from 3000 to 10,000 milliseconds and a corrupted nonin 7600 driver was found and changed for a nonin 8600 driver.

• Brand Name: OXYCON PRO
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• 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 ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5428961
• MDR Text Key: 38483155
• Report Number: 2021710-2016-03156
• Device Sequence Number: 1
• Product Code: BZC
• Combination Product (y/n): N
• PMA/PMN Number: K992214
• 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: 02/12/2014

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: OXYCON PRO
• Device Catalogue Number: 001-143960
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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