MAUDE Adverse Event Report: AMBU A/S AMBU SPUR II INFANT TUBE RES.; MANUAL RESUSCITATOR

Catalog Number	544212031
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident is under investigation.A mdr follow up will be submitted when the final investigation has been concluded.
Event or Problem Description
Resuscitation bag would not hold peep.Patient was not affected, able to use another bag (not ours) and avoided admitting the patient.
Event or Problem Description
Resuscitation bag would not hold peep.Patient was not affected, able to use another bag (not ours) and avoided admitting the patient.
Additional Manufacturer Narrative
The incident is under investigation.A mdr follow up will be submitted when the final investigation has been concluded.December 1, 2025 - mdr follow up 1.Total 9 pcs samples were returned.All samples were received in good condition; no obvious cosmetic defect was found.All spur ii, peep valve and manometer were performed and passed function, which means these samples are within specification.A simulation test as customer's videos was performed.Per test results, during one expiratory phase all spur ii pre-attached with peep valve and manometer could keep positive pressure in patient connector.It is observed that the pressure minor drops over time when peep tends to stabilize, which is caused by the spur ii pre-attached with peep valve and manometer is not a completely sealing part.Connections e.G.Between peep valve and spur ii; between compressible bag and patient valve housing; are connected by mechanical structure, not by gluing, and slight air would escape between connections.However, when following iso 10651-4:2009 to perform delivered volume test on returned samples (spur ii pre-attached with peep valve and manometer), all samples pass delivered volume test.All returned samples are within specification, spur ii could hold peep, the reported failure could not be duplicated.In addition, all products are 100% performed function test before delivery to ensure the product within specification.Spur ii ifu has a warning "always inspect the resuscitator and accessories (e.G.Face mask, peep valve, filters, etc.) and perform a functional test after unpacking, cleaning, assembly and prior to use" and states how to perform function test; peep valve has a warning "always use the ambu disposable peep 20 valve with a manometer as the manometer ensures correct adjustment of peep during ventilation".This is the first complaint about spur ii not being able to hold peep in the past 1 year.No failure was detected on returned samples.We will continue to monitor this defect and will take necessary actions as required.

• Brand Name: AMBU SPUR II INFANT TUBE RES.
• Common Device Name: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 23414909
• Report Number: 1220828-2025-00025
• Device Sequence Number: 18749780
• Product Code: OEV
• UDI-Device Identifier: 05707480153374
• UDI-Public: 05707480153374
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/01/2025
• Report Date (Section F): 12/01/2025

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 Catalogue Number: 544212031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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: 12/01/2025