MAUDE Adverse Event Report: AMBU A/S SPUR® ADULT RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number	520611061
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During ventilation with nursing and anesthesia, oxygen saturations continued to decline when it was noticed that ambu face mask was attached to where the peep [positive end expiratory pressure] valve attaches.

• Brand Name: SPUR® ADULT RESUSCITATOR
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU A/S; 6721 columbia gateway drive; suite 200; columbia MD 21046
• MDR Report Key: 24230208
• Report Number: 24230208
• Device Sequence Number: 13004621
• Product Code: BTM
• UDI-Device Identifier: 05707480154074
• UDI-Public: (01)05707480154074
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/22/2026
• Report Date (Section F): 01/22/2026

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: Health Professional
• Device Model Number: 520611061
• Device Catalogue Number: 520611061
• Device Lot Number: 2000007190
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Date Report Sent to FDA: 01/22/2026