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

Model Number 3100A

Device Problems Failure to Cycle (1142); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

The following description of the event was copied from a warranty claim submitted by the foreign distributor in (b)(6)."the alarm paw<20% of set max always active.A circuit can be under pressure only when the reset button is pressed.The 3100 was checked with other operable alarm board and it worked properly".

Manufacturer Narrative

Neither the foreign user facility nor the foreign distributor submitted a suer 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, on 01/06/2015 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 01/13/2015 the alleged faulty alarm board has not been received.Should the alleged faulty alarm be returned and evaluated, a f/u 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: 4438154
• MDR Text Key: 5387930
• Report Number: 2021710-2015-00046
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/09/2014

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: 768909
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/09/2014
• Device Age: 1 YR
• Event Location: Other
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1