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

Model Number 3100B

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

Patient Problem No Patient Involvement (2645)

Event Date 01/03/2014

Event Type  malfunction  

Event Description

The following description of the event was documented by a carefusion tech support specialist in response to a phone conversation with a user facility representative(s) on (b)(6) 2014."[name removed] called and he states that he is trying to do the performance check and the amplitude jumps up past 199 and is off the scale of the panel meter.He wanted to know what to check.I suggested checking e pressure transducer to see if water might have gotten into it.He doesn't have the top cover off of the unit yet but will check.He asked for the part number of the pressure transducer.Gave him 122-8006, (b)(4).I also gave him the part number for the airway pressure tubing, 770115, (b)(4).He will call back only if he doesn't think the transducer is not the issue." 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) called to confirm that the 3100b vent referenced in the medwatch report was probably (b)(4) because he remembers that it was only this one with "water ingress." 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 ken and was told that he was out today and tomorrow.Please reference uf 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.The following information concerning the evaluation of the device is a summary of the information documented by a carefusion tech support specialist in response to a phone conversation with a user facility biomed rep.The carefusion technical support specialist in conjunction with the customer determined that condensate may have migrated through the patient circuit into the proximal sense line and into the pressure transducer which resulted in the reported event.The carefusion technical support specialist advised the user facility biomed to replace the pressure transducer and proximal sense line.On (b)(4) 2014, replacement components were sent to the user facility for their biomed to repair and return this device to an in use condition.As stated in the 3100b operator's manual, this situation is known to occur ift he pt 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: 4001743
• MDR Text Key: 4690244
• Report Number: 2021710-2014-00037
• 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,User Facility
• 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

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3100B
• Device Catalogue Number: 770155
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/03/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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
• Treatment: ASKU