MAUDE Adverse Event Report: RESMED PTY LTD NV ACUCARE F1-0 FFM SML-EU1 5PK; CANNULA, NASAL, OXYGEN

Model Number	60786
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to resmed that the elbow of an acurcare non-vented f1-0 full face mask with lot number 1445428 detached from the frame assembly after 30 minutes of use.Patient's oxygen saturation dropped, mask was replaced and no further intervention was required.
Additional Manufacturer Narrative
The mask has been returned to resmed for investigation.The investigation methods, results and conclusion are not finalized at this stage.The acucare f1-0 mask is a hospital non-vented full-face mask which is intended to be used in a hospital environment only.Therefore, it is expected that the patient is under supervision.The user guide also provides the following caution: ¿if any visible deterioration of a mask system component is apparent (cracking, discoloration, tears etc.), the mask system should be discarded and replaced.¿ resmed reference#: (b)(4).
Additional Manufacturer Narrative
The mask has been returned to resmed for investigation.Visual inspection confirmed the elbow did not fully assemble into the frame and can easily be detached.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a combination of partial assembly between the elbow and the frames during manufacturing at supplier and the slanted and rounded edge of the elbow snap feature.The acucare f1-0 mask is a hospital non-vented full-face mask which is intended to be used in a hospital environment only.Therefore, it is expected that the patient is under supervision.The user guide also provides the following caution: ¿if any visible deterioration of a mask system component is apparent (cracking, discoloration, tears etc.), the mask system should be discarded and replaced.¿ 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 the elbow of an acurcare non-vented f1-0 full face mask with lot number 1445428 detached from the frame assembly after 30 minutes of use.Patient's oxygen saturation dropped, mask was replaced and no further intervention was required.

• Brand Name: NV ACUCARE F1-0 FFM SML-EU1 5PK
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 20425732
• Report Number: 3007573469-2024-00336
• Device Sequence Number: 15554181
• Product Code: CAT
• UDI-Device Identifier: 00619498607860
• UDI-Public: (01)00619498607860(10)1445428
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 12/19/2024
• Report Date (Section F): 12/19/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 60786
• Device Catalogue Number: 60786
• Device Lot Number: 1445428
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/28/2024
• Device Age: 53 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Date Report Sent to FDA: 12/19/2024