MAUDE Adverse Event Report: AMBU A/S AMBU SPUR II PEDIATRIC RESUSCITATOR; MANUAL RESUSCITATOR

Model Number	531600051
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither sample nor picture was returned for investigation.Therefore the reported failure of spur ii having a blocked manometer port, could not be verified.As the sample was not returned, the investigation of the malfunction was conducted by reviewing the production records.The records showed that the reported spur ii item may have been manufactured with a blocked manometer port on the patient valve housing.The defect could have been caused due to a damaged tool pin durin ght molding process for the patient valve housing.The blocked manometer port was not detected by the function tests performed in the spur ii assembly line.To mitigate that this defect occurs again a corrective action (ca-000948) has been initiated.The molding tool has been repaired and a quality control check point on the manometer port has now been added into the working instructions for the injection control procedure for the patient valve housing.In addition, a requirements to verify that the test equipment used to test 'manometer port passage' is efficient, has been added.Ambu will keep monitoring the issue and take actions as appropriate.
Event or Problem Description
A customer reported that a second lot for spur ii with blocked manometer port was found.The affected bags were pulled.No patient involvement.

• Brand Name: AMBU SPUR II PEDIATRIC RESUSCITATOR
• Common Device Name: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU LTD.; complex building no. c; xiang yu f.t.z; xiamen, 36100 6; CH 361006
• Manufacturer Contact: michelle leu ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 22183766
• Report Number: 9610691-2025-00013
• Device Sequence Number: 12888199
• Product Code: OEV
• UDI-Device Identifier: 05707480163441
• UDI-Public: 05707480163441
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

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: Other
• Device Model Number: 531600051
• Device Catalogue Number: 531600051
• Device Lot Number: 2000015577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown