MAUDE Adverse Event Report: RESMED PTY LTD AIRFIT F30I CONDUIT LGE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	63370
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Resmed has requested for the device to be returned so that an investigation can be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.The airfit f30i user guide provides the following warning: - ¿if any visible deterioration of a system component is apparent (cracking, discoloration, tears etc.), the component should be discarded and replaced.¿ the user guide also provides the following warning: -¿the mask must be used under qualified supervision for patients who are unable to remove the mask by themselves.This mask is not for use on patients with impaired laryngeal reflexes or other conditions predisposing to aspiration in the event of regurgitation or vomiting.¿ resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
Event or Problem Description
It was reported to resmed that a piece of an airfit f30i mask broke off while in use on a patient.It was reported that the patient may have swallowed the broken piece during the night while asleep.There was no report of the patient seeking medical attention or treatment due to the reported issue.

• Brand Name: AIRFIT F30I CONDUIT LGE
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 19243327
• Report Number: 3007573469-2024-00116
• Device Sequence Number: 7430749
• Product Code: BZD
• UDI-Device Identifier: 00619498633708
• UDI-Public: (01)00619498633708(10)1666663
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2024
• Report Date (Section F): 05/03/2024

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: Lay User/Patient
• Device Model Number: 63370
• Device Catalogue Number: 63370
• Device Lot Number: 1666663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2024
• Device Age: 16 MO
• Date Report to Manufacturer: 05/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2024
• Date Device Manufactured: 11/09/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 05/03/2024