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	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ambu sales representative reported that spur ii had a blocked manometer port.This reported failure was verified during the investigation of the returned samples.No reading was obtained from the manometer, when applying pressure to the spur ii bag.The production records showed that the reported defect could have been caused due to a damaged tool pin during the molding injection process for the patient valve housing.The blocked manometer port was not detected during quality control in the spur ii assembly line, by neither visual inspection nor the test machine performing the function test (ins-000986 rev.12) for 'manometer port passage'.It is suspected that the test machine not having detected the manometer port issue could have been due to test machine being worn out.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 to improve visual inspection of the manometer port.In addition, a requirement to verify that the test machine 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
An ambu sales representative was checking his spur ii stock and detected 3 pieces of spur ii with occluded manometer port, rendering the manometer non-functional.There was no patient involvement or harm reported.

• 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: 22227814
• Report Number: 9610691-2025-00015
• Device Sequence Number: 21005109
• Product Code: OEV
• UDI-Device Identifier: 05707480163441
• UDI-Public: 05707480163441
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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