MAUDE Adverse Event Report: CAREFUSION, INC INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number SIPAP

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device was returned and evaluated without information regarding patient involvement.Carefusion become aware of patient involvement and adverse event after device had already been evaluated and returned to the customer.Results of investigation: the carefusion failure analysis laboratory received the suspect device for investigation.An investigation was performed and the reported issue was unable to be duplicated.There was no findings from visual and thorough on board diagnostics.The suspect device operated as intended.As a precautionary measure, the sensor valve printed circuit board assembly was replaced.

Event Description

The customer reported while using the infant flow sipap; the unit stopped working during patient use.The customer reported the unit shut down.The customer reported e12, e33, e42, e51, e53, e55 error codes in the events log.The customer performed troubleshooting, but the issue was not resolved.The customer reported the unit displays error code 30 every time on power-up.The customer reported there is no patient consequence associated with the event.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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
• MDR Report Key: 6214905
• MDR Text Key: 63607724
• Report Number: 2021710-2016-05153
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIPAP
• Device Catalogue Number: 675-CFG-004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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
• Patient Outcome(s): Required Intervention