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

Model Number SIPAP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results of investigation: the carefusion factory service center received the suspect device, a sipap unit, and evaluated the device.An evaluation of the device duplicated the reported issue and found the blender was out of calibration and the 100% o2 pin stopper was damaged.Factory service repaired the unit and the unit meets service specifications.

Event Description

The customer reported that the o2 was reading 67% when the blender knob was set at 60%, per the internal o2 sensor and an external analyzer.There was no patient involvement associated with the reported issue.

• 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: 6214635
• MDR Text Key: 63801385
• Report Number: 2021710-2016-05133
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIPAP
• Device Catalogue Number: 675-CFG-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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