MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC FILTER BACTERIAL RT STANDARD NO PORT; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number DYNJAABV1

Device Problems Moisture Damage (1405); Occlusion Within Device (1423); Increase in Pressure (1491)

Patient Problem Dyspnea (1816)

Event Date 06/09/2015

Event Type  malfunction  

Manufacturer Narrative

The following elements have blank data.

Event Description

Rt (respiratory therapist) called to the patient's bedside because the patient's co2 end-tidal was reading 80+ and minimal breathing sounds could be heard.The rt found that the medline filter in line with the servo-i-vent was completely full of water and obstructing the flow through the ventilator.Filter in place for less than 24 hours.After replacing the filter, the patient's breathing sounds improved greatly and the end-tidal co2 fell back into normal range for the patient.We have seen two separate events involving the medline filters being used alongside with the servo-i-vents.This patient required additional monitoring as a result of this device event to ensure that there was no harm to the patient.In the picu, we are seeing an increased pressure in the circuit/servo i vents due to water saturating the filters.When staff have switched back to the older filters, they are not having these issues.

• Brand Name: FILTER BACTERIAL RT STANDARD NO PORT
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein, IL 60060
• MDR Report Key: 4988423
• MDR Text Key: 22442839
• Report Number: 4988423
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: DYNJAABV1
• Device Lot Number: 15DB5054
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 YR