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

Model Number 325002000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is resubmitted as it was discovered that this mdr has not been successfully loaded into fdas database.The initial reporting to fda of this case has been done to fda within the original deadline, however in the wrong file format to support correct upload.This submission represents a reload of data to ensure correct upload to the fda database.The spur ii was returned from customer.The reported fault was verified, and the inlet valve disc was found to have come off inside the inlet valve housing.Testing concluded that the product did not fulfil the specification of delivering >85% oxygen concentration in accordance with en iso 10651-4, particular requirements for operator powered resuscitators.Resuscitation/ventilation with ambient air is still possible and within specifications.Testing has also concluded that the failure can be detected when performing the prescribed functional pre-check per the ifu.

Event Description

The customer reports that the inlet valve had come off in the spur ii and when using the product under a procedure, the oxygen saturation of the patient dropped to 77%.The fault was detected after approximately 45 min and was counteracted by using another oxygen source.The patient was not affected by the incident.

• Brand Name: AMBU SPUR II
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 12108039
• MDR Text Key: 262206875
• Report Number: 9610691-2019-00009
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K152931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 325002000
• Device Lot Number: 1000160900
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• 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): Required Intervention