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

Model Number 3100A

Device Problems Device Alarm System (1012); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 01/13/2014

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 suspected pwb dvr disp indicator pcba pn 766504, sn (b)(4) was returned to carefusion for evaluation.It was installed into a known good 3100a test vent and found that, on ic u7 the input is changing state and then 90ms later, the output changes state but then falls back to its original state.The cause of the start/stop switch does not stop the machine from oscillating allegation, is that u7 is defective.Duplicated, the start/stop button does not stop the oscillations, complaint allegation.This issue has been address via internal actions.

Event Description

The following description of the event was received via an email from carefusion (b)(6) (tech support) on (b)(6) 2014.Set up and filled the gas, at the first time.Pressed the start / stop button, the 3100a started to oscillate, but after a while, this button cannot stop oscillating.There is no warning alarm with sound or lights flashing on the panel.They rebooted the 3100a, pressed the star / stop button, but the machine cannot oscillate even if they press the button of sw1 (oscillation button) many times, the 3100a can't be oscillated; but the mean airway pressure remains unchanged.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY / LSZ
• 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: 5412880
• MDR Text Key: 38132341
• Report Number: 2021710-2016-02844
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• 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: 766522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1