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.
Additional Manufacturer Narrative
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.Above all, all returned samples are within specification, spur ii could hold peep, the reported failure could not be verified.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 hold peep in the past 1 year.No failure was detected on returned samples.For this case, the patient outcome not affected, the risk to patient is acceptable.No corrective action is required now, we will keep monitoring.
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.

• Brand Name: AMBU SPUR II INFANT TUBE RES.
• Common Device Name: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU LIMITED; no. c, warehouse & process; complex building xiang yu ft.z; xiamen, fujian province 36100 6,; CH 361006,
• Manufacturer Contact: catharina engelhardt ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 23411281
• Report Number: 9610691-2025-00025
• Device Sequence Number: 21103491
• Product Code: OEV
• UDI-Device Identifier: 05707480153374
• UDI-Public: 05707480153374
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K152931
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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