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

Catalog Number	520611048E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer: "today during a full arrest with t20, they had to send a member out to the medic unit to grab a new ambu bag because the one they were using collapsed and will not expand.The second ambu bag which they grabbed from a medic unit worked flawlessly." ambu bag was deflated upon opening, would not sufficiently fill the bag.When cincinnati fire arrived on the scene, the patient was too far gone already.The bag was not responsible for patients' death.A second bag was used and worked as indicated.Patient expired.The bag was not responsible for patients' death.
Additional Manufacturer Narrative
No sample could be returned for investigation, but the reported failure could be verified per the picture provided by customer.Spur ii is assembled and packed manually according to internal procedure.Before packing, function tests are performed.If there is deformation, it should be easily detected by function test or operators.Therefore, the product should be without deformation before delivery.Since customer did not provide the lot number and no sample is returned for investigation, production record could not be reviewed.Per transportation test, the product should not be deformed under normal transportation conditions.One possible cause of such malfunction is if spur ii stored in a deformed state.We tried to get more information about storage condition, but no further information from customer apart that spur ii was stored in a red bag.The ifu states: "never store the resuscitator in a deformed state other than as folded when delivered by the manufacturer, otherwise permanent distortion of the bag will occur which may reduce the ventilation efficiency" and "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".Ambu will keep monitoring the issue and take actions as appropriate.

• Brand Name: SPUR II ADULT BAG RESUSCITATOR
• 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: 22802795
• Report Number: 9610691-2025-00021
• Device Sequence Number: 7836812
• Product Code: OEV
• UDI-Device Identifier: 05707480154050
• UDI-Public: 05707480154050
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: 520611048E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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