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

Model Number 3100B

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2014

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 transducer pn 122-8006 and a coiled tubing pn770115.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

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 report that condensation got up into the pressure xdcr and coiled tubing.They were checking out the vent and noticed murky water inside the coiled tubing.There was no indication of patient harm.

• 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: 5418351
• MDR Text Key: 38228484
• Report Number: 2021710-2016-03025
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• 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: 06/19/2004
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2003
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1