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

Model Number 3100B

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 09/25/2013

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.The device/components were not returned for possible failure analysis evaluation.

Event Description

The customer reported the vent originally came down with a blender issue, but now the driver does not start.Carefusion technical support representative determined that the blender was not giving proper gas flow to vent (low source gas light) and also reminded the customer to what alarm conditions were and how to check them.Carefusion technical support representative further explained the "low source gas" and how the ventilator has to be pressurized in order for the driver to start; and suggested bypassing the blender, taking the "wye/t-connector" out of the equation, and then evaluating the blender and ventilator separately.The customer reached out the carefusion moments later seeking to order a driver power module.Carefusion technical support representative asked if the vent ever pressurized and that is why he suspects a faulty driver power module (driver not starting).Customer said 'no' explaining that the vent still doesn't pressurize and the low source gas light was still on after bypassing the blender.Support rep, explained the vent and how the driver will not start without pressure and this is a pneumatic issue; suggested evaluating the pneumatic pressure switch, pressure transducer, and regulators.Support rep recommend that he find a "known good circuit" so the circuit could be ruled out.No further details were provided, 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: 5418353
• MDR Text Key: 38248336
• Report Number: 2021710-2016-02988
• 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: 09/25/2013

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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2008
• 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