MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC VENTILATION MASK; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE

Model Number	100/905/360
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.
Event or Problem Description
It was reported that the edges of the breathing mask of the cpap system ere empty, so that an airtight connection with the face could not be achieved.The mask was switched to resolve the issue.There was no additional information provided.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Unable to determine when or what caused the mask edges to become deflated.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: PNEUPAC VENTILATION MASK
• Common Device Name: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13769555
• Report Number: 3012307300-2022-04558
• Device Sequence Number: 14099122
• Product Code: BYE
• UDI-Device Identifier: 15019315079207
• UDI-Public: 15019315079207
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: 100/905/360
• Device Catalogue Number: 100/905/360
• Device Lot Number: 4009017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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