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

Model Number 22 E

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 07/18/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results of investigation: the carefusion failure analysis lab received the suspected component and performed a failure investigation.Visual examination of the mass flow board, as received, revealed a burnt capacitor, c58.It was determined that the burnt capacitor could have caused the power cables error.

Event Description

The customer reported that while booting up the encore 22 e device, she received check cables and interface error messages.It is unknown if there was any patient involvement at the time of the issue.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION, INC; 1100 bird center drive; palm springs CA 92262
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6051698
• MDR Text Key: 58525179
• Report Number: 2031702-2016-01175
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/24/2016

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: 22 E
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 10/24/2016
• 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: Unknown
• Patient Sequence Number: 1