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

Model Number	520211000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported failure is a hole in the ambu bag, which caused the user to be unable to oxygenate the patient.Despite ambu's efforts in obtaining the faulty device, neither sample nor picture was returned for investigation and therefore the reported failure could not be verified.In addition, no information could be obtained on whether the hole was in the reservoir bag or in the compressible bag.If a hole in reservoir bag: after reservoir bag is assembled a 100% visual inspection on the reservoir bag is conducted to confirm if the edge is melted well.Furthermore, 100% reservoir test is performed.Therefore a hole in the reservoir bag should be easily detected during manufacturing.After reviewing production records, no abnormality was found.The product should therefore have been within specifciations before delivery.Possible causes for a hole in the reservoir bag could be that the bag was cut by a sharp object, or reservoir bag being pulled during handling despite the accompanying ifu stating "do not pull as tearing may occur", or the reservoir bag not being welded well.If the reported failure is about a hole in spur ii reservoir bag, then it is the 5th complaint received this past year.The accompanying ifu states "always inspect the rescucitator and accessories (e.G.Face mask, peep valve, filters etc.) and perform a functional test after unpacking, cleaning, assembly and prior to use" and description of how to conduct a function test for "oxygen reservoir bag" is included in the ifu.If a hole in compressible bag: during manufacturing a high/low pressure test is performed on all spur ii.A hole in the compressible bag would cause air leaking and it is easility detected when conducting the high/low pressure test.After reviewing production record, no abnormality was found.Therefore, there should not be a hole in the compressible bag before delivery.A hole in the compressible bag may be possible due to the compressible bag being cut by a sharp object during use.Due to limited information, the root cause is unknown.If the reported failure is about a hole in the compressible bag, then this is the 3rd complaint about such failure this past year.The ifu states "always inspect the resuscitator and accesories (e.G.Face mask, peep valve, filters, etc.) and perform a functional test after unpacking, cleaning, assembly and prior to use.Therefore this failure could be easily detected prior to use.The root cause for the reported failure could not be determined, and no corrective action is required for now.Ambu will keep monitoring the issue and take appropriate actions.
Event or Problem Description
The customer reported: patient needed an emergency airway.When anesthesia went to get the ambu bag, they were not able to oxygenate the patient due to a hole in the ambu bag.No patient harm was reported in the mdr report (mw5169454) from medwatch, but the reports states that intervention was required.During ambu's follow-up correspondance with the customer, the customer explained that they replaced the faulty ambu bag with a new functional ambu bag.Efforts were made to otbain further knowledge on whether the patient condition was affected by the malfunction.No response was received.

• Brand Name: AMBU SPUR II ADULT BAG RES.
• Common Device Name: MANUAL PULMONARY RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 22105918
• Report Number: 1220828-2025-00011
• Device Sequence Number: 12799386
• Product Code: OEV
• UDI-Device Identifier: 05707480151554
• UDI-Public: 05707480151554
• 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: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/29/2025
• Report Date (Section F): 05/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 520211000
• Device Catalogue Number: 520211000
• Device Lot Number: 1001036562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2025
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown