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

Model Number 3100A

Device Problem Failure to Power Up (1476)

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

Event Date 09/24/2013

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 were not returned for possible failure analysis evaluation.

Event Description

The following event reported to carefusion, occurred in (b)(6): the customer reported the oscillator stopped alarm; depress and hold reset.Mean airway pressure can rise; press the start/stop button.The oscillator canstart.According to the complaint form, this event occurred during patient usage.No further details were provided.

• 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: 5418223
• MDR Text Key: 38249867
• Report Number: 2021710-2016-03003
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/09/2013

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: 3100A
• Device Catalogue Number: 766522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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