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

Model Number 3100B

Device Problems Failure to Sense (1559); Moisture or Humidity Problem (2986)

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

Event Date 01/03/2014

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 customer was sent a pressure xdcr and a proximal sense line.As of this date the parts have not been received for evaluation.When they have been received and evaluated a supplement will be filed.

Event Description

(b)(4) was received by customer advocacy june 9, 2014.The report stated: two sensormedics high frequency ventilators (models 3100a and 3100b) have failed in use in recent months.The investigation found water ingress into the proximal airway line which caused the pressure sensors to fail.I have comments from the manufacturer that contradict each other and pictures of the internal circuit of the machine if required.Manufacturer's response: technical support #1: "water ingress frequently occurs on the 3100b because it uses a shorter circuit.Dependent on patient y position."technical support #2 (from manual): "a trickle flow of dry gas from the blender flows constantly from the 3100b to the patient y to keep water vapor from even partially obstructing this pressure sensing pathway".

• Brand Name: CAREFUSION
• 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: 5419729
• MDR Text Key: 38435228
• Report Number: 2021710-2016-03053
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1