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

Catalog Number	520611000
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still in progress.
Event or Problem Description
Customer had a sealed ambu spur ii adult resuscitator that did not have a mask in the sealed package.Patient condition was not affected, attempted to be used on a patient, but the nurse was unable to due to the missing mask.She had to go get another ambu bag from a different crash cart.There was a slight delay in patient care, but the patient's care was not affected.
Event or Problem Description
Customer had a sealed ambu spur ii adult resuscitator that did not have a mask in the sealed package.Patient condition was not affected, attempted to be used on a patient, but the nurse was unable to due to the missing mask.She had to go get another ambu bag from a different crash cart.There was a slight delay in patient care, but the patient's care was not affected.
Additional Manufacturer Narrative
The sample was disposed by customer, neither sample nor picture is available for investigation, so visual inspection has not been performed.The reported failure cannot be verified.During the manufacturing of spur ii, there are two processes that can detect missing face mask.Firstly, 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.Secondly, 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.And then the kit needs to be re-inspected before packing into carton.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, a new face mask was obtained.There was a slight delay in patient care, but the patient's outcome was not affected.A corrective action is already on-going to improve this issue, we will keep monitoring.

• Brand Name: AMBU SPUR II ADULT BAG 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: 24330063
• Report Number: 9610691-2026-00003
• Device Sequence Number: 9744840
• Product Code: OEV
• UDI-Device Identifier: 05707480151776
• UDI-Public: 05707480151776
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: Health Professional
• Device Catalogue Number: 520611000
• Device Lot Number: 1001061530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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