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

Model Number 3100B

Device Problems Overheating of Device (1437); Device Inoperable (1663)

Patient Problem No Information (3190)

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).A carefusion field service representative visited the user facility to evaluate the device.During the course of the evaluation the field service representative noted: customer reported oscillator overheated and stopped.Circuit was still attached and settings preserved.They were 3 hz, % it 35.And power set at 10.Inspection revealed that driver diaphragm had a large tear and was very degraded.Performed 8k preventative maintenance, patient circuit calibration @ 40 cmh2o, and performance test @ 26.7 cmh2o paw/131 cmh2o amplitude.Replacement driver assy returned to failure analysis lab for additional evaluation, the evaluation is not yet available.

Event Description

The customer reported the unit overheated and stopped running on a patient; the unit alarm correctly.No further details received.

• 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: 5418251
• MDR Text Key: 38237362
• Report Number: 2021710-2016-03032
• 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: 10/29/2013

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2013
• 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