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	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that there was no hole for the manometer.The manometer port was blocked, rendering the manometer non-functional.There was no patient involvement as the defect was observed prior to use.
Additional Manufacturer Narrative
The device was received 25th of june 2025 by the ambu inc.In us, but the sample has not been investigated by the investigation team in malaysia yet.
Additional Manufacturer Narrative
Initial report july 02, 2025: the device was received 25th of june 2025 by the ambu inc.In us, but the sample has not been investigated by the investigation team in malaysia yet.Follow up report august 20, 2025: one sample was returned for investigation.During the investigation it was found that the reported failure of the spur ii had a blocked manometer port, which could be verified by the returned sample.No reading was obtained from the manometer when applying pressure to the spur ii bag.The cause of the failure has been traced to a damaged tool pin used during the molding process of housing (injection control procedure).The blocked manometer port was not detected during quality control.To prevent this failure from occuring again, the injection control procedure for patient valve housing hae been updated with a visual check point for the manometer port (done on (b)(6) 2025).Furthermore, the production control procedure for spur ii, has been updated to add an efficiency check for the test machine performing the function test (done on (b)(6) 2025).In addition, a capa (ca-000948) has been raised for the issue.Ambu will keep monitoring the issue and take actions as appropriate.
Event or Problem Description
Customer reported that there was no hole for the manometer.The manometer port was blocked, rendering the manometer non-functional.There was no patient involvement as the defect was observed prior to use.

• Brand Name: AMBU SPUR II PEDIATRIC RESUSCITATOR
• Common Device Name: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 22382268
• Report Number: 1220828-2025-00016
• Device Sequence Number: 13120815
• 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: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025
• Report Date (Section F): 08/20/2025

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: 2000015181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/04/2025
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/20/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/20/2025