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

Model Number 520611001

Device Problem Inflation Problem (1310)

Patient Problem Cardiac Arrest (1762)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

The two affected samples were contaminated, therefore they could not be used for investigation and the reported failure could not be verified.According to the customer complaint, the first affected spur ii was connected to the oxygen flow which initially inflated it.However, after the patient was intubated and took a breath, the device would not re-inflate again.In fact, neither the bag nor the reservoir would inflate and stayed in a collapsed state.This sequence of events repeated with the second spur ii.Afterward, when the patient was stabilized, the two affected products were tested by the user.The resuscitators were connected to a high flow of oxygen, and they seemed to perform as expected.During the manufacturing process all the resuscitators undergo a function test to verify that the finished products meet the design specifications.Compressible bags are verified to be able to inflate back to their default shape and the reservoir bags are verified to be able to fill with oxygen if connected to oxygen supply.This is the first complaint about compressible and reservoir bags not inflating at the same time in the past year.Possible causes for the compressible bag not to re-inflate are dents (refuted by the pictures of affected samples) or inlet valve disc malfunction.Possible causes for the reservoir bag not to fill with oxygen are damaged or bags sticking or leaking inlet valve chambre.However, the root cause could not be determined since the samples could not be used for investigation due to samples being contaminated, (per china customs, their local protocol refuses entry of contaminated samples).We will continue to monitor this product.

Event Description

Per the customer, "patient was being electively intubated.Ambu was hooked up to oxygen and bag initially filled.Immediately after intubation, the rt gave a breath and the ambu bag failed.It would not refill.The reservoir end bag would not fill and the part of the bag that you squeeze would not recoil to the open position.The patient proceeded to cardiac arrest while the secondary ambu mask was obtained from the room next door.It also failed, the bag would not inflate.The third bag was grabbed and hooked up and was used on the patient.They obtained rosc, and patient was placed onto the vent.I am unsure how long the patient was down without oxygen.".

• Brand Name: AMBU SPUR II ADULT BAG RES.
• Type of Device: AMBU SPUR II ADULT BAG RES.
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 17291537
• MDR Text Key: 318750656
• Report Number: 1220828-2023-00014
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/13/2023,07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 520611001
• Device Catalogue Number: 520611001
• Device Lot Number: 1000646561; 1000804646
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other