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

Model Number	60788
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mask was returned to resmed and an evaluation confirmed the reported complaint.An initial investigation has determined that the root cause is 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.¿ the reportable event occurred outside the us.During a routine check of complaints records it was detected that the event is reportable in the us.This report is being submitted to correct the error.Resmed reference#: pr (b)(4).
Event or Problem Description
It was reported to resmed that the elbow component of an acucare non-vented f1-0 full face mask did not fit and was disconnected from the mask during installation on a patient.There was no patient harm or a serious injury reported as a result of this incident.
Additional Manufacturer Narrative
The mask was returned to resmed.An investigation determined that the root cause is 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 component of an acucare non-vented f1-0 full face mask did not fit and was disconnected from the mask during installation on a patient.There was no patient harm or a serious injury reported as a result of this incident.

• Brand Name: NV ACUCARE F1-0 FFM LGE-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
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 19842151
• Report Number: 3004604967-2024-00218
• Device Sequence Number: 7595000
• Product Code: CAT
• UDI-Device Identifier: 00619498607884
• UDI-Public: (01)00619498607884(11)230712(10)1715756
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 60788
• Device Catalogue Number: 60788
• Device Lot Number: 1715756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/28/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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