MAUDE Adverse Event Report: CAREFUSION CAREFUSION; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Inaccurate Delivery (2339)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation by the carefusion failure analysis technician is anticipated but has not yet begun.(b)(4).

Event Description

The customer reported that the frequency on the ventilator is not linear, when he turns the freq.Knob counter clockwise the driver speeds up and when the knob is turned clockwise the driver slows down.No patient involvement.

Manufacturer Narrative

The carefusion failure analysis engineer examined the driver controller pcba assy and found that the frequency control knob functions normally.However, on u1, ic-ina110kp the output at pin 9 is stuck at -2.8vdc.This caused the reading on the frequency hz display to be stuck at (1.).Most probably, this circuit acted strange as it failed and possibly could have caused the issue that the customer reported.Duplicated, problem with frequency control, complaint allegation.Defective, u1 ic-ina110kp, output is stuck at -2.8vdc.

• Brand Name: CAREFUSION
• 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 60061 ; 8473628056
• MDR Report Key: 5052963
• MDR Text Key: 25506603
• Report Number: 2021710-2015-01554
• 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: user facility
• Reporter Occupation: Health Professional
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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