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

Model Number 3100A

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

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

The following description of the event is a summary of the information provide via an email from the distributor in (b)(4).Distributor emailed reporting that he has a 3100a ventilator that failed the installation.No patient involvement.The audible alarm continually sounds whether the 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

(b)(4).The following information concerning the evaluation of the device is a summary of the information 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 the foreign distributor a replacement alarm board.Carefusion issued a return goods authorization (rga) number to the foreign distributor for the return of the alleged faulty alarm board for evaluation.As of january 14, 2015, the alleged faulty alarm board has not been received.Should the alleged faulty alarm board be returned and evaluated, a follow-up medwatch report will be submitted.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer Contact: antonio cervera ; 1100 bird center dr.; palm springs, CA 92262 ; 7607787307
• MDR Report Key: 4438179
• MDR Text Key: 5387932
• Report Number: 2021710-2015-00057
• 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
• 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