MAUDE Adverse Event Report: CAREFUSION 3100A PRODUCT; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2014

Event Type  malfunction  

Manufacturer Narrative

This medwatch 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.The customer was sent a replacement pwb driver assembly pn766504.As of this date the part has been received for evaluation.Once it has been evaluated a supplement will be filed.

Event Description

The following description of the event was documented by a carefusion tech support specialist in a response to a phone conversation with a user facility representative on (b)(6) 2014.The customer called to report that when the start/stop button is depressed sometimes it engages and other times it doesn't.There was no indication of patient involvement.

Manufacturer Narrative

Failure analysis (fa) received and examined a ddi board (3100a).An investigation was performed and verified the reported issue.The failure was due to a defective u7 on the ddi board.Output of pins u7.1 and u7.2 would not toggle.

• Brand Name: 3100A PRODUCT
• 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: marshall thompson ; 7607787307
• MDR Report Key: 5420130
• MDR Text Key: 38290958
• Report Number: 2021710-2016-03068
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 768901-103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1