MAUDE Adverse Event Report: AMBU A/S DISPOSABLE FACE MASK; DISP MASK LARGE W/CHECK VALVE

Catalog Number	000252956
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither sample nor picture were available; therefore the reported failure cannot be verified.The dissatisfaction is mainly related to the shape and clinical use of the mask.No manufacturing defects were identified.After reviewing the design input requirements of reported sample, the requirements of product sealing property have been considered and verified in the design input.To accommodate variability in facial characteristics and the sealing with the skin on the patient's face, the disposable face mask is designed in 6 sizes and thin cushion wall thickness.In the ifu, it has stated all the methods to ensure the sealing property when using disposable face masks.The customer stated that "to keep the mask stable on the patient's face, the involvement of two operators is often required, with a negative impact on the practicality and efficiency of the procedure." it seems the face mask can ultimately achieve a seal when sufficient force is applied, but only with the assistance of two operators holding it in place throughout the process.The reported sample has a hook ring which can connect the head strips to fix the face mask on patients' face.In the ifu, it also has guidance of using head strips connect to hook ring.Hence, the user's problem can be solved in this way.The customer used to work with king masks, since end 2025- beginning 2026, they switched from ambu king masks to disposable face masks.The king masks feature a thinner, softer cushion compared to disposable face masks, which may contribute to the worse user experience when switching to the latter.In this complaint, patient was involved but outcome not affected.This is the second complaint that customer is unsatisfied with the design of disposable face mask, and the other complaint is also from this customer.It is considered as isolate case.No corrective action is needed now, we will keep monitoring.
Event or Problem Description
It was difficult to ventilate the patient, as the mask was not adhering correctly to patient's face.Patient desaturated during anesthesia induction.Patient had to be ventilated by two people simultaneously as there was severe desaturation.

• Brand Name: DISPOSABLE FACE MASK
• Common Device Name: DISP MASK LARGE W/CHECK VALVE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, denmark 2750 ; DA 2750
• MDR Report Key: 24971272
• Report Number: 1220828-2026-00009
• Device Sequence Number: 4978982
• Product Code: BYG
• UDI-Device Identifier: 05707480023363
• UDI-Public: 05707480023363
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 000252956
• Device Lot Number: 1001242574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2026
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown