MAUDE Adverse Event Report: AMBU A/S SPUR II

Catalog Number 325023000

Device Problem Device Handling Problem (3265)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Type  malfunction  

Event Description

According to customer report: after successful intubation, the patient was not ventilated with the spur ii.Patient desaturated with 28% and developed bradycardia with a decrease of 30 bpm.The spur ii was changed and the patient was then ventilated and stabilized.It was subsequently determined that the first resuscitator was equipped with a pressure-limiting valve and the second without.The patient needed a very high ventilation pressure (over 40 mmh2o), which was only possible with the second resuscitator bag without pressure-limiting valve.The difference between the resuscitator bags can be seen on labels: "ambu spur ii" and "ambu spur ii single patient use resuscitator".An inquiry with the manufacturer revealed that there had been changes to the medical devices and that now only resuscitators with pressure-limiting valves were available.Customer complained that the pressure-limiting valve on the spur ii resuscitators are open when the resuscitator is delivered and that the resuscitator from the customer's point of view therefore poses a risk to the patient in an emergency situation as not enough pressure is built up.From the customer's point of view, it would be desirable if the resuscitators where delivered with the pressure-limiting valve closed leaving it for the user to decide if it should be opened.Patient could be stabilized.No harm to patient occurred.

Manufacturer Narrative

Based on information from the customer it appears that the user was not aware of close the pressure-limiting valve in order to build up the requested pressure.According to ifu "the pressure-limiting valve is set to open at 40 cm h2o (4.0kpa).If medical and professional assessment indicates a pressure above 40 cm h2o, it is required, the pressure-limiting valve can be overridden by moving the override clip onto the valve.Alternatively, the pressure-limiting valve can be overridden by placing a finger on the red button while squeezing the bag".Iso 10651-4 for operator-powered resuscitators is being updated at the moment and has just been voted in favor of.According to the update to standard "a means shall be provided to prevent the airway pressure from exceeding the maximum limited pressure for more than 200 ms".The pressure-limiting valve support the fulfillment of this requirement.The resuscitators are delivered with the pressure-limiting valve open in order to reduce the risk of generating barotraume on the patient by ventilating with an unintentional high pressure.

• Brand Name: SPUR II
• Type of Device: SPUR II
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 16504582
• MDR Text Key: 310956109
• Report Number: 1220828-2023-00008
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 325023000
• Device Lot Number: 1000741908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other