MAUDE Adverse Event Report: AMBU A/S AMBU® SPUR® II; MANUAL RESUSCITATOR

Catalog Number	325002000
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated when he opened the plastic bag for patient use there was no mask inside the bag.No impact to patient.
Additional Manufacturer Narrative
The reported sample was received in opened original pouch, no face mask attached to resuscitator, the reported failure can be verified.The assembly process was performed according to packaging procedures, first, one operator needs to put face mask cover on the patient valve and put them into pouch.After pouch sealed, 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, another operator put the spur ii kit into box and place a cardboard lid on the top of facemask connector.After packaging, the fqcs conduct sample inspection for each lot.If the face mask was omitted during assembly, it is easy to detect.And 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.Itis easily detected before use.In this complaint, no patient was involved, it is low risk to patient.We have raised a corrective action to improve this issue, we will keep monitoring.

• Brand Name: AMBU® SPUR® II
• 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: 25251195
• Report Number: 9610691-2026-00014
• Device Sequence Number: 9725368
• Product Code: OEV
• UDI-Device Identifier: 05707480151776
• UDI-Public: 05707480151776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: 325002000
• Device Lot Number: 1001242711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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