MAUDE Adverse Event Report: AMBU A/S AMBU SPUR II ADULT BAG RES.

Catalog Number	520611000
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An ambu spur ii was identified as defective supply.The product should be supplied with mask for bagging patients.Facemask was not included, this supply did not reach a patient, this is the second time this has occurred.
Additional Manufacturer Narrative
The reported sample was not available, but a picture was received, no face mask was attached to resuscitator.The reported failure can be verified.During manufacturing of spur ii, there are two processes that can detect missing face mask.First process, in accordance with packaging procedures, one operator needs to attach face mask to the swirl connector.Then, the product will undergo packing and pouch sealing process.If a face mask is not assembled on the resuscitator, the operator of next process can easily detect it.Second process, every spur ii kit undergoes 100% weighting, if face mask is missing, the weight of this kit will exceed the set tolerance, triggering a red-light alarm and a buzzer alarm.Then the operator needs to check if the quantities of accessories are correct.After packaging, the fqcs conduct sample inspection for each lot.We have reviewed all relevant production records and qc inspection records, no abnormality was found.The customer reported when they found the face mask was missing, the carrying bag was sealed.Based on above analysis, the causes of this failure might be that the face mask was omitted during packaging.But due to limited information the root cause is unknown.This failure has been defined in product risk file.In the ifu, it also states to inspect the accessories prior to use.It is easily detected before use.In this complaint, no patient was involved.A corrective action is already on-going to improve the issue and keep monitoring the issue.

• Brand Name: AMBU SPUR II ADULT BAG RES.
• Common Device Name: AMBU SPUR II ADULT BAG RES.
• 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: bolette walldorf ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 24814477
• Report Number: 9610691-2026-00007
• Device Sequence Number: 6012152
• Product Code: OEV
• UDI-Device Identifier: 05707480151776
• UDI-Public: 05707480151776
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: 520611000
• Device Lot Number: 1001191765
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• 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