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

Model Number 3100A

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation by (b)(4) is anticipated but has not yet begun.(b)(4).

Event Description

The customer reported that the ventilator will hold pressure fine but when he depresses the start/stop button the unit won't start and the oscillator stopped alarm will sound.No patient involvement.

Manufacturer Narrative

The carefusion failure analysis technician examined the driver power module assy and found that it does not operate.Installed driver power module into a known good 3100a test vent and found that the driver did not operate when the start/stop button was pushed.Noted that the led on the p.W.M.Module was very dim red and did not change to green.Replaced the p.W.M.Module with a known good p.W.M.Module and found that the 3100a test vent now functions normally.Duplicated, the unit won't start and the oscillator stopped alarm will sound, complaint allegation.

• 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 ; 8473628056
• MDR Report Key: 5094115
• MDR Text Key: 26661556
• Report Number: 2021710-2015-01701
• 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: 08/27/2015

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: 768901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2005
• 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