AMBU A/S SPUR II ADULT-POP, CLOSED, ULTACLEAR, MEDIUM ADULT; AMBU SPUR II ADULT RESUSCITATOR, AMBU SPUR II PEDIATRIC RESUSCITATOR, AMBU SPUR
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Catalog Number 325012000 |
Device Problem
Failure to Deliver (2338)
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Patient Problems
Cardiac Arrest (1762); Vomiting (2144); Cerebral Edema (4403)
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Event Date 05/09/2022 |
Event Type
Death
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Manufacturer Narrative
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One resuscitator without a face mask attached was returned for investigation.The returned sample is not in its original package.Per visual inspection, all the components of the returned sample are in their own position and no damage can been seen on its appearance.Function tests, including the delivered volume testing, high/low pressure testing and oxygen concentration testing, have been performed to verify the returned sample's functionality.Based on above testing results, this returned sample is still able to deliver sufficient air volume and no air leakage nor blockage can been seen.From the complaint information, the reported failure of patient unable to be ventilated means no air was delivered to the patient.And this suspected product was ever tested to be able to work properly before use but occurred to fail to ventilate the patient who vomited a lot.This unit was tested afterwards and can function as it should and the device complaint cannot be confirmed.The ambulance personnel experienced "a lot of resistance" during ventilation, which means the ventilated air cannot be delivered to the patient.For such a situation, two possibilities could contribute to it.One is that there was blockage in the resuscitator, and the other is that the patient airway was probably blocked by the vomit.Since this sample can pass the tests above as well as the visual inspection, it can be concluded that no problem detected on this sample and the possibility of resuscitator malfunction should be excluded.Furthermore, ambu spur ii product passes a 100% function test in manufacturing process before delivery to customer.In case the patient airway is being blocked and no air is ventilated, the instruction for use states that if the patient vomits during mask ventilation, the user should immediately clear the patient's airway and then freely compress the bag a few times before resuming ventilation and when encounter a continued resistance to insufflation, the user should check the airway for obstruction.Without following such instructions, the ventilation would not able to be achieved.
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Event Description
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Ambulance called for an un witnessed cardiac arrest in the parking garage.There was heroin user equipment next to the patient, the security guard started cpr.Ambulance personnel took over on arrival at 23:00 and they can not ventilate the patient.Lots of vomiting, but it also seems that disposable ventilation bags do not work properly.The doctor in the ambulance arrives at 23:05 and takes over the patient, tests the mask ventilation and find the same problem, intubates the patient quickly, uses a bag from his own device, ventilates well.Tests the first bag again and experiences again that it does not ventilate the patient.When tested afterwards, they do not find any defects in the bag.The patient eventually receives spontaneous circulation and is delivered to ullevål hospital intubated.Ct immediately after arrival at the hospital shows global cerebral edema, after 24 hours of intensive care, the brain's circulation is stopped and the patient dies.
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