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

Model Number 3100A

Device Problems Break (1069); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2014

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.When the needle valve has been received and evaluated a supplement report will be filed to provide that detail.

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 order a needle valve.They state that the old needle valve on the unit seemed to be damaged / broken.They installed a new needle valve and it passes the circuit calibration and all the pneumatics calibrations come into specification, but it seems to be very sensitive to movement.When they turn the knob to about the 12 o'clock position the unit seems to dump pressure.He is requesting a replacement needle valve.

Manufacturer Narrative

Failure analysis (fa) lab received a 3100a needle valve assy.The fa lab performed an investigation and was unable to duplicate the reported issue.

• 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: 5414113
• MDR Text Key: 38126443
• Report Number: 2021710-2016-02849
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2014

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: 768901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1