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

Model Number 3100B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported that after installing the patient circuit and connecting the supply gasses and powering up the unit, the oscillator started to run without pressurizing the circuit and pressing the start/stop switch.There was no patient involvement associated with the reported issue.

Manufacturer Narrative

The vyaire medical failure analysis laboratory received the suspect component, a 3100b driver displacement indicator (ddi) printed circuit board assembly (pcba), and evaluated the device.An evaluation of the component did not duplicate the reported issue as the component meets manufacturer's specifications.

Manufacturer Narrative

The vyaire medical factory service center and failure analysis laboratory received the suspect components, a 3100b 3 ohm driver assembly, a 3100b driver controller board, and a 3100b alarm printed circuit board assembly (pcba), and evaluated the devices.An evaluation of the components duplicated the reported issue and isolated the issue to pin 4 of ic u6 on the driver controller board was stuck in high state.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6210828
• MDR Text Key: 63710747
• Report Number: 2021710-2016-05115
• 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,Followup,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 08/02/2017; 11/13/2017
• Supplement Dates FDA Received: 08/09/2017; 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2004
• 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