MAUDE Adverse Event Report: CAREFUSION 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problems Mechanical Problem (1384); Loss of Power (1475)

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

Event Date 04/18/2014

Event Type  Injury  

Manufacturer Narrative

Results of investigation: the pressure regulator was returned to carefusion's failure analysis laboratory.An investigation was performed; however, the reported issue could not be duplicated.The power driver module assembly was returned to carefusion¿s failure analysis laboratory.An investigation was performed and the driver controller pcba (printed circuit board assembly) was found to have damaged resistor components.The driver assembly was returned to carefusion¿s failure analysis laboratory.An investigation was performed and the reported issue was duplicated.The cause of the reported issue was traced to an unbalanced coil, which resulted in damage inside the coil by overheat.

Manufacturer Narrative

This medwatch 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)(6) was sent a 3 ohm driver assembly pn 24-773937, a driver power module pn 24-772714 and a cooling gas regulator pn: 772775.As of this date the parts have not been received for evaluation.When they been received and evaluated a supplement will be filed.

Event Description

The following description of the event was received via an email from (b)(6) on (b)(6) 2014.(b)(6) reported that the unit did shut off with no preview warnings, the on/off button did mechanical go off also.This occurred while on a patient.Two nurses were in the room to empty the water trap when this happened.They did turn the unit on, but it did turn itself off after a couple of seconds.The patient was bagged and switched to a backup unit.The patient was unharmed.

• Brand Name: 3100 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 ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5994022
• MDR Text Key: 56558930
• Report Number: 2021710-2016-02983
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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,Followup
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 770881-102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention