MAUDE Adverse Event Report: INTERSURGICAL UAB AIR-GUARD CLEAR BREATHING FILTER

Model Number 1790030

Device Problem Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

During use, the filter was used at the patient and experienced high pressure.The air guard filter is for use at machine end connections in anesthesia, itu, or homecare breathing system applications.It is designed to reduce bacterial/ viral transmissions in order to protect oxygen concentrator machines and respiratory equipment, as noted in ifu occlusion or high resistance during use - nebulized drugs, excess secretions, placing filter below patient airway in the circuit.

Event Description

One of our anesthesia providers encountered difficult high pressure while a patient was intubated.He removed the hepa filter and replaced it with another.He was not sure if it was a bronchial spasm or the filter.This filter was placed at the patient.I informed end user this filter should be placed at the machine.He will return the filter so we can investigate.

• Brand Name: AIR-GUARD CLEAR BREATHING FILTER
• Type of Device: BREATHING FILTER
• Manufacturer (Section D): INTERSURGICAL UAB; arnioniu 60/28-1; pabrade, lh, lithuania ; LH
• Manufacturer Contact: ivan seniut ; arnioniu 60/28-1; pabrade, vilniaus apskritis, LT-47-10 ; LH LT-4710
• MDR Report Key: 10245523
• MDR Text Key: 198093404
• Report Number: 1319447-2020-00003
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/05/2020

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?: No
• Device Operator: No Information
• Device Model Number: 1790030
• Device Lot Number: 31952616
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention