MAUDE Adverse Event Report: RESMED 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	Low Oxygen Saturation (2477)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to resmed that a patient, admitted to the hospital for cardiopulmonary arrest for an acute coronary syndrome with stented trivessel involvement, desaturated during ventilation while using an acucare full face mask.It was reported that the ventilation circuit disconnected from the mask and the same issue occurred when another mask from same batch was used.It was reported that the ¿disconnection¿ allegedly happened during mask storage and that the connector on the mask (elbow) did not fit in its housing.A new mask from a different batch was used and the issue was resolved.
Additional Manufacturer Narrative
The acucare f1-0 ffm mask was returned to resmed.The investigation methods, results, and conclusions are not finalized at this stage.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).H3 other text : pending investigation.
Event or Problem Description
It was reported to resmed that a patient, admitted to the hospital for cardiopulmonary arrest for an acute coronary syndrome with stented trivessel involvement, desaturated during ventilation while using an acucare full face mask.It was reported that the ventilation circuit disconnected from the mask and the same issue occurred when another mask from same batch was used.It was reported that the ¿disconnection¿ allegedly happened during mask storage and that the connector on the mask (elbow) did not fit in its housing.A new mask from a different batch was used and the issue was resolved.
Additional Manufacturer Narrative
The acucare full face mask was returned to resmed for an investigation.The reported complaint was confirmed as the elbow and frame of the mask were disconnected when the mask was received.No visual anomalies were observed.The investigation determined that the reported complaint was due to a partially assembled frame-elbow assembly during manufacturing at supplier.The risk associated to a partially assembled frame-elbow assembly has not changed from the original risk assessment and it is considered acceptable.Root cause is currently under further investigation.Additionally, 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).

• Brand Name: NV ACUCARE F1-0 FFM LGE-EU1 5PK
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17760699
• Report Number: 3007573469-2023-00510
• Device Sequence Number: 6768004
• Product Code: CAT
• UDI-Device Identifier: 00619498607884
• UDI-Public: (01)00619498607884(11)230308(10)1692998
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/25/2024
• Report Date (Section F): 04/25/2024

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: 60788
• Device Catalogue Number: 60788
• Device Lot Number: 1692998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/28/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 04/25/2024
• 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 Age: 66 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/25/2024