MAUDE Adverse Event Report: AMBU A/S SPUR II RESUSCITATOR; MANUAL RESUSCITATOR

Catalog Number 522611000

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2021

Event Type  Death  

Manufacturer Narrative

A part of the spur ii was reported to be missing.This resulted in insufficient resuscitation of a patient.The patient died.No sample was returned for investigation.Per confirmation by the customer, the reported issue was that the outlet connector on the patient valve was missing due to a use error.Someone had removed expiratory/outlet connector on the customer side in order to use it with another spur ii resuscitator.The reported product was manufactured and controlled in accordance with the working instructions.100% visual inspection and 100% function testing is performed on spur ii to make sure the product is performing as specified when delivered to the customer.It is stated in the instructions for use that a functionality precheck should always be performed before using the product on a patient.Had this been done, the user would have discovered that a piece was missing and other means of resuscitation could have been used instead.

Event Description

Patient was not receiving adequate ventilation during code blue resuscitation event.It was identified that the ambu bag was missing the outlet connector.The outlet connector is designed to be removable to allow user to clear the valve chamber.The outlet connector should never be removed during operation.A user error was made.It was stated by an employee at the health care facility that someone had decided to take the outlet connector from the device to use with another resuscitator.The user complained that the packaging of the spur can be opened and closed and still appear untouched.It wasn't realized by the user that the outlet connector was missing before it was too late for the patient.The patient died.The prescribed precheck was not performed in accordance with the instructions for use.If a precheck had been made, the missing piece would have been identified and other means of resuscitation could have been used.

• Brand Name: SPUR II RESUSCITATOR
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 11986716
• MDR Text Key: 255821265
• Report Number: 1220828-2021-00006
• 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: Other
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 522611000
• Device Lot Number: 1000422792
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2021
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death