MAUDE Adverse Event Report: AMBU A/S AMBU® SPUR® II ADULT RESUSCITATOR; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number	523611030
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Unopened ambu-bag removed from sealed packaging found to be missing face mask portion of the device delaying patient care until a new device could be obtained.

• Brand Name: AMBU® SPUR® II ADULT RESUSCITATOR
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): AMBU A/S; 6721 columbia gateway drive; suite 200; columbia MD 21046
• MDR Report Key: 22976491
• Report Number: 22976491
• Device Sequence Number: 15800520
• Product Code: OEV
• UDI-Device Identifier: 05707480149476
• UDI-Public: (01)05707480149476
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2025
• Report Date (Section F): 07/24/2025

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: Health Professional
• Device Model Number: 523611030
• Device Catalogue Number: 523611030
• Device Lot Number: 2000010862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Date Report Sent to FDA: 07/24/2025