MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. HUMIDIFICATION PORTEX THERMOVENT HME SYSTEMS

Model Number THERMOVENT T2 HM EXCHANGER-JPWITH

Device Problem Filtration Problem (2941)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Information received a smiths medical humidification|portex thermovent hme systems during the use of the product, the customer noticed the both sides of the filters turned into green.No patient injury.

Manufacturer Narrative

Corrected data: dpfg: mdr=no.Device is a distributed purchased finished good; smiths medical is only a distributor with no manufacturing or design responsibilities.

Event Description

Humidification|portex thermovent hme systems event of filters turning green is not reportable to fda.

• Brand Name: HUMIDIFICATION PORTEX THERMOVENT HME SYSTEMS
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10408478
• MDR Text Key: 203707886
• Report Number: 3012307300-2020-08196
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: THERMOVENT T2 HM EXCHANGER-JPWITH
• Device Catalogue Number: 100/570/022J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1