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

Model Number VMAX ENCORE 229D W/O GAS REG

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 07/19/2016

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.

Event Description

The company representative reported while using the static and dynamic compliance; the hot wires between pins of the flow sensor were melted.The customer stated the device was not used on a patient for pulmonary function testing at the time of the event.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis laboratory received the suspect mass flow sensor.Visual examination of the mass flow sensor, as received, revealed the filaments to be burned.The reported "middle hot wire between pins are melted" failure was confirmed.The failure analysis technician determined the root cause to be due to material fatigue.This was noted that this can occur at any time during use whenever the mass flow sensor has reached the end of life.Results of investigation: the carefusion failure analysis laboratory received the suspect mass flow sensor.Visual examination of the mass flow sensor, as received, revealed the filaments to be burned.The reported "middle hot wire between pins are melted" failure was confirmed.The failure analysis technician determined the root cause to be due to material fatigue.This was noted that this can occur at any time during use whenever the mass flow sensor has reached the end of life.Upon further risk assessment, there is no danger of patient harm or user harm at the time of the filament failure as the hot wires are contained inside the plastic sensor housing and do not come in contact with the end user or patient at any time during use.Therefore the initial mdr should have not been submitted.This failure is unlikely to cause harm or injury to a patient or user.

• 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: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5845462
• MDR Text Key: 51885454
• Report Number: 2021710-2016-04158
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

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 229D W/O GAS REG
• Device Catalogue Number: 777401-103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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