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

Model Number SIPAP

Device Problems No Audible Alarm (1019); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At this time, carefusion has not received the suspect device/component from the customer for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The user facility reported that during testing, after turning on the sipap, the e80 alarm was on the screen.The customer switched off the unit and the power fail alarm did not sound.The user switched the unit on and the e80 alarm was not present on the screen.The user switched the unit off again and the power fail alarm did not sound.The e80 alarm appeared in the diagnostic menu.There was no patient involvement associated with the reported issue.

Manufacturer Narrative

The carefusion failure analysis laboratory received the suspect device, a sipap ventilator, and evaluated the device.An evaluation of the device duplicated the reported issues.The reported error code e80 was found to be caused by a defective speaker assembly, with open impedance.The reported issue of no audible alarm when the unit was shut off was isolated the issue to a super capacitor on the main printed circuit board assembly (pcba) not holding charge.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Type of Device: VENTILATOR, NON-CONTINUOUS
• 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: 6201471
• MDR Text Key: 63483240
• Report Number: 2021710-2016-05102
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K031745
• 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: 06/27/2017

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: SIPAP
• Device Catalogue Number: 27476-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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