MAUDE Adverse Event Report: CAREFUSION CAREFUSION; VENTILATOR, HIGH FREQUENCY/LSZ

Model Number 3100A

Device Problems False Alarm (1013); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

The following description of the event is a summary of the info provided via an e-mail from the distributor in (b)(6).Distributor emailed reporting that he has a 3100a ventilator that failed the installation.No patient involvement.The audible alarm continually sounds whether an alarm condition is present or not.They took a known good alarm board and installed into the vents to verify that a replacement alarm board was necessary to resolve the issue.

Manufacturer Narrative

The foreign distributor did not submit a user facility/importer report to the mfr.Event codes were derived based on info provided by the foreign distributor.(b)(4).The following info concerning the evaluation of the device is a summary of the info provided by the foreign distributor.The foreign distributor evaluated the device and determined the failure was caused by a malfunctioning alarm board.To repair the device , carefusion sent to a foreign distributor a replacement alarm board.Carefusion issued a return good authorization (rga) number to the foreign distributor for the return of the alleged faulty alarm board for evaluation.As of 01/14/015 the alleged faulty alarm board has not been received.Should the alleged faulty alarm board be returned and evaluated, a f/u medwatch report will be submitted.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY/LSZ
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer Contact: antonio cervera ; 1100 bird center dr.; palm springs, CA 92262 ; 7607787307
• MDR Report Key: 4438163
• MDR Text Key: 5379087
• Report Number: 2021710-2015-00059
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/16/2014

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: Other
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/16/2004
• Device Age: 9 MO
• Event Location: Other
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1