MAUDE Adverse Event Report: CAREFUSION HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problems Crack (1135); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/07/2013

Event Type  malfunction  

Manufacturer Narrative

This initial 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.(b)(4).The device/components documented as returned, failure analysis evaluation is not available.

Event Description

The customer reported a couple of circuits that seem to be cracking at the temp port sites.She said the part number of the circuits is 773996.She has one circuit with lot# 0000558519 and that circuit has a cracked temp port closest to where the temp port is.She has another circuit with unknown lot# with a cracked temp port on the one further down on the circuit.She said that they seemed to happen when they were setting the circuits up to calibrate them.Carefusion technical support specialist informed, wiping the ports off with alcohol and then putting the temp probes in the port before the alcohol has dried can cause issues like that.She said she is aware of that and the rts are aware but she isn't sure if that is what happened on these circuits.Patient involvement is unknown.

• Brand Name: HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• 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: jill rittorno ; 7149227830
• MDR Report Key: 5426485
• MDR Text Key: 38480934
• Report Number: 2021710-2016-03075
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/07/2013

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: Health Professional
• Device Model Number: 3100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2013
• Initial Date FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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