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

Model Number 3100A

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The carefusion failure analysis technician will evaluate the alleged failed part if it is returned to the manufacturer.

Event Description

The customer reported that the frequency meter of the unit does not display the right frequency values.No patient involvement.

Manufacturer Narrative

Failure analysis (fa) lab received and examined a panel meter and found no problems.The panel meter was installed in known good 3100a unit and found to function normally.The returned panel meter was tested side by side with a known good panel meter and the two meters tracked perfectly with each other.The customers issue of the frequency meter of the unit does not display the right frequency values could not be duplicated.The panel meter was scrapped.

Manufacturer Narrative

Failure analysis (fa) lab received a driver controller pcba and found the display was not displaying the correct frequency.Fa installed the driver controller pcba into a known good 3100a unit and found the display was not displaying the correct frequency.Fa found that with the correct inputs on pins 1 and 2 the frequency control signal was now present.Pin 9 of ui was out of range at 3.87vdc to 4.11vdc.This caused the display to read out of range high.The reported issue was duplicated due to a defective ui.The driver controller pcba was scrapped.

• 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 ; 75 n. fairway drive; vernon hills, IL ; 8473628056
• MDR Report Key: 5032054
• MDR Text Key: 25010122
• Report Number: 2021710-2015-01477
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup,Followup
• Report Date: 07/27/2015

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: 3100A
• Device Catalogue Number: 768909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/05/2016; 04/21/2016; 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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