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

Model Number VMAX ENCORE 22D

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported the suspect component is available for analysis and an return good authorization (rga) has been issued.At this time, carefusion has not received the suspect component for evaluation.If additional information becomes available, it will be submitted in a follow up report.

Event Description

The customer reported while using the vmax encore, a smell of smoke was noticeable while warming up the unit.The issue occurred with no patient involvement.

Manufacturer Narrative

The vyaire failure analysis lab received the suspected device and performed a failure investigation.The failure analysis technician confirmed burnt tracings on the analyzer control board (777348-101).The root cause is the operator error-assembly and is an isolated incident.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6661466
• MDR Text Key: 78355340
• Report Number: 2021710-2017-06170
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

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: VMAX ENCORE 22D
• Device Catalogue Number: 777405-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 10/31/2017
• Supplement Dates FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1