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

Device Problem Inflation Problem (1310)

Patient Problem Respiratory Insufficiency (4462)

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

Unfortunately, due to no feedback from customer, the report failure could not be identified.Indeed, neither the sample nor the picture have been provided by the customer.According to the information received, we could understand that two spur ii resuscitators were used in an emergency situation but they could not inflate properly.This compromised the patient´s condition, who was hypoxic and the staff could not oxygenate the patient appropriately.We can not know specific issue on two ambu bags from these information.However, during the manufacturing, all spur ii resuscitators are 100% performed function test for reservoir bag to make sure the finished products meet the design specification, so the reservoir bag of spur ii should inflate to ventilate sufficient oxygen to patient during normal use.As said before, due to limited information and no sample or picture, the specific failure and root cause could not be determined.The risk for this failure has been evaluated in product risk and it is concluded as acceptable.This reported failure could be found before using on patient per function test as stated in ifu "always inspect the resuscitator and perform a functional test after unpacking, cleaning, assembly and prior to use".Due to limited information, specific failure and root cause could not be determined, no corrective action is defined now.

Event Description

"two faulty ambu bags that were used in an emergent situation last eve in cvicu.The reservoir portion of two ambu bags would not inflate.The ambu bags were sequestered and are being sent to security for holding." item number and lot number unknown, item number picked for complaint filing purposes only.Patient care was compromised, "this did compromise patient care as the patient was hypoxic and the staff were unable to oxygenate the patient appropriately due to the defective ambu bags.".

• Brand Name: AMBU SPUR II ADULT BAG RESUSCITATOR
• Type of Device: AMBU SPUR II ADULT BAG RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer Contact: giulia salierno ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 16972397
• MDR Text Key: 315659403
• Report Number: 9610691-2023-00014
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening