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

Model Number 3100A

Device Problems Device Inoperable (1663); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The carefusion field service engineer evaluated the ventilator and replaced the driver power module to fix the reported issue.(b)(4).

Event Description

The customer reported that the ventilator was making noises while on a patient, the patient was removed from the ventilator and placed on another oscillator.During testing, the customer reported that the oscillator stopped by itself.No patient harm.

Manufacturer Narrative

The carefusion failure analysis engineer examined the driver power module and found that it is functioning normally.Installed driver power module into a known good test unit and operated it at the standard settings for 24 hr.With no problems.Unit was heated and cooled with no affects.Could not duplicate complaint allegation that the system intermittently stops.

• 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: 5053045
• MDR Text Key: 25425585
• Report Number: 2021710-2015-01555
• 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

• Is this an Adverse Event Report?: Yes
• 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: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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
• Patient Outcome(s): Required Intervention