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

Model Number 3100A

Device Problems Moisture Damage (1405); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/03/2014

Event Type  malfunction  

Event Description

The following additional information concerning the event was documented by a carefusion tech support specialist in response to a phone conversation with a user facility representative on (b)(4) 2014.[name removed] (biomed) states that he doesn't know about the 3100a, but [name removed] would know.He doesn't understand why [name removed] felt the need to file a medwatch report since he knows why/how this happens.He suggested that i email [name removed].I told him that i did email [name removed].Please reference user facility report: (b)(4).

Manufacturer Narrative

The user facility did not provide any patient codes on their user facility report.Codes were derived based on the information contained on the user facility medwatch report received from the fda on (b)(4) 2014.On (b)(4) 2014, after several previous attempts to contact the initial reporter, a carefusion technical support representative was able to contact a biomed at the user facility.The biomed was unable to verify that a 3100a high frequency oscillator ventilator had experienced this issue as mentioned on the user facility medwatch report.He does not remember any 3100a high frequency oscillatory ventilator having this issue recently.The biomed also informed the carefusion technical support representative that they are well aware of how and why water ingress occurs and that he does not understand why a medwatch report was submitted by his facility.As stated in the 3100a operator's manual, this situation is a known to occur if the patient circuit is not supported to the proper height and angle.Proper angle will allow condensate (water ingress) to run downward into the water trap mounted on the column.However, failure to set the patient circuit to the proper height and angle could result in collection of humidifier condensate in the patient airway.Should additional information became available, a follow-up medwatch report will be submitted.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY/LSZ
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: antonio cervera ; 7607787307
• MDR Report Key: 4001740
• MDR Text Key: 4706535
• Report Number: 2021710-2014-00036
• 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: Other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/03/2014

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: Other
• Device Model Number: 3100A
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/03/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASKU