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

Model Number 3100A

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2013

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).Date is not available.The device/components were not made available for evaluation.

Event Description

The customer reported this unit and 2 other units were put on a patient and they all seemed to lose power and stop running.The customer detailed, they put one on then tried another and another etc.There was no patient harm and the units did alarm correctly.Customer requested field service.

• 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: 5418308
• MDR Text Key: 38249820
• Report Number: 2021710-2016-03034
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• 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: 10/30/2013

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: 768901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2013
• 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