MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. AIR SAFETY HEPA AND NON-HEPA FILTERS; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	62.002.0090.9064/711CRSA
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was return for evaluation but video was provided.Investigation was done by the supplier.The defect is not caused by the manufacturing process, as it is during use.The possible root cause is that the issue was caused by the influence of humidity conditions.The amount of water in this product is affected by the humidity and flow rate in the filter, but in the case of high humidity, the hme filter moisture accumulates inside the-and the flow resistance increases.The allegation was not confirmed.Operator of device is unknown.This remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the product was occluded due to absorption of excessive amount of water in its heat and moisture exchange(hme) filter.The filter needed to be replaced.No patient injury was reported.

• Brand Name: AIR SAFETY HEPA AND NON-HEPA FILTERS
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-21-2 motohama-cho, naka-ku,; minneapolis, MN 55442
• MDR Report Key: 15427010
• Report Number: 3012307300-2022-19240
• Device Sequence Number: 7530045
• Product Code: CAH
• UDI-Device Identifier: 15019315083303
• UDI-Public: 15019315083303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 62.002.0090.9064/711CRSA
• Device Catalogue Number: 002823P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown