MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX THERMOVENT HEPA HME BREATHING FILTER; FILTER, BACTERIAL, BREATHING-CIRCUIT

Catalog Number C1038J

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Manufacturer Narrative

No product information has been provided to date.

Event Description

It was reported that during the pre-use check of this device, an air leak alarm sounded.No additional information was available.No patient was involved.

Manufacturer Narrative

Other, other text: three (3) pictures were provided.One photo displayed a top view of a circuit product.The other pictures showed sections of circuit damage.The returned sample was visually inspected.The problem was confirmed, due to a hole in the circuit.The failure reported could not be reproduced using tools from the assembly process.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced.The damage (hole) was made, after the product left the facility.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.No lot number was provided for performance of a device history record review.

• Brand Name: PORTEX THERMOVENT HEPA HME BREATHING FILTER
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14655568
• MDR Text Key: 293731562
• Report Number: 3012307300-2022-11548
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C1038J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1