MAUDE Adverse Event Report: CAREFUSION HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 11/22/2013

Event Type  malfunction  

Manufacturer Narrative

This initial report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.(b)(4).The alleged faulty bellows water trap (p/n (b)(4)) has been received into carefusion (b)(4) failure analysis lab and is currently awaiting investigation.

Event Description

An event which occurred (b)(6) as follows: event details three bellows returned to local thai business partner with a complaint of fault during hfov therapy.Upon visual inspection, the black rubber has become detached at points from the clear plastic body.Private hospital site, therefore circuits used in compliance with single patient use.Circuits collected by (b)(4) business partner and handed ((b)(4)).Patient involvement is unknown.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis lab received the suspected device/component and performed a failure investigation.The reported issue was duplicated and confirmed in the laboratory setting.The root cause of the reported issue was a defective adhesive bond between the bellows diaphragm and bellows housing as a result of the devices being manufactured in 2009 and the adhesive appears old and yellowed.

• Brand Name: HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 7149227830
• MDR Report Key: 5426465
• MDR Text Key: 38479964
• Report Number: 2021710-2016-03085
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2013

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: 3100B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2013
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1