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

Model Number 3100A

Device Problems Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

Should any additional information be received by the customer then an additional report will be submitted.(b)(4).At this time, carefusion has not received the suspect device/component from the customer for evaluation.

Event Description

The customer reported that this 3100a high frequency oscillating ventilator was being used on a patient when the device started to emit a "burning" odor and made a loud "humming" noise.Alternate ventilation was provided by changing out the unit with a known good unit and the customer stated that there was no patient injury or harm associated with this issue.

Manufacturer Narrative

Results of investigation: a carefusion field service representative (fsr) evaluated the device onsite.The fsr performed preventative maintenance and completed performance testing.The unit meets manufacturer's specifications.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis laboratory received the suspect component, a 3100a fan assembly, and evaluated the device.An evaluation of the component duplicated the reported issue and isolated the issue to a solder bridge on the printed circuit board assembly (pcba).

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5817650
• MDR Text Key: 50288585
• Report Number: 2021710-2016-04105
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention