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

Model Number 3100B - RFB

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the ventilator will run fine for a few minutes, then he will see the amplitude slowly come down then to zero and it will alarm oscillator stop.He said the unit will keep running though and alarm oscillator stopped.No patient involvement.

Manufacturer Narrative

The carefusuion failure analysis technician examined the alarm pcba and found that it operates normally.Installed pcba into a known good test unit and operated it for 100 hr.With no problems.Heated pcba and found that the delta pressure reading dropped to zero, the oscillator stopped led came on and the audible alarm came on.Upon heating, the output of ic u1 quad opamp became distorted.This caused the delta p voltage and the oscillator stop sense voltage to go low causing the delta p reading to go to zero and the oscillator stopped alarm to sound.Duplicated the amplitude slowly came down then to zero and it will alarm oscillator stop complaint allegation.Finding/root-cause: duplicated, the amplitude slowly came down then to zero and it will alarm oscillator stop, complaint allegation.Defective ic u1 quad opamp tl1014.It is heat sensitive and will intermittently malfunction.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• 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: 5004045
• MDR Text Key: 23203980
• Report Number: 2021710-2015-01393
• 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: user facility
• Reporter Occupation: Health Professional
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B - RFB
• Device Catalogue Number: 770155-RFB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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