MAUDE Adverse Event Report: WESTMED INC. BACTERIAL/ VIRAL FILTER WESTMED; FILTER, BACTERIAL, BREATHING-CIRCUIT

Device Problem Material Separation (1562)

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

Event Date 08/04/2020

Event Type  malfunction  

Event Description

Bacterial/viral filter connected to the anesthesia breathing circuit separated.This is not the first report on these filters.Happening at another hospital in our system also.

• Brand Name: BACTERIAL/ VIRAL FILTER WESTMED
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): WESTMED INC.; 5580 s nogales hwy; tucson AZ 85706
• MDR Report Key: 10406980
• MDR Text Key: 202910209
• Report Number: 10406980
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1