MAUDE Adverse Event Report: AMBU A/S SPUR II ADULT-POP, CLOSED, ULTACLEAR, MEDIUM ADULT; AMBU SPUR II ADULT RESUSCITATOR, AMBU SPUR II PEDIATRIC RESUSCITATOR, AMBU SPUR

Catalog Number 325012000

Device Problem Use of Device Problem (1670)

Patient Problems Cardiac Arrest (1762); Vomiting (2144); Cerebral Edema (4403)

Event Date 05/09/2022

Event Type  Death  

Event Description

Ambulance called for an unwitnessed cardiac arrest in the parking garage.Patient shown to be a heroin user, by the 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 the 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 found 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 (b)(6) 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.

Manufacturer Narrative

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 there was no problems detected on this sample and the possibility of the resuscitator malfunctioning should be excluded.Furthermore, ambu spur ii product passes a 100% function test in manufacturing process before delivery to the 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 encountering 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.This catalog number is not distributed in the u.S.

• Brand Name: SPUR II ADULT-POP, CLOSED, ULTACLEAR, MEDIUM ADULT
• Type of Device: AMBU SPUR II ADULT RESUSCITATOR, AMBU SPUR II PEDIATRIC RESUSCITATOR, AMBU SPUR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 14746757
• MDR Text Key: 294373659
• Report Number: 1220828-2022-00008
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 325012000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2022
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death