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

Model Number 325023000

Device Problem Obstruction of Flow (2423)

Patient Problem Cardiovascular Insufficiency (4445)

Event Date 12/26/2019

Event Type  Injury  

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.Prior to release, inspiratory/expiratory resistance test are performed at ambu for all spur¿ ii products to ensure performance according to specifications.The risk is included and evaluated as acceptable in the product risk evaluation.For one of the cases, the device has been returned to ambu for investigation.For the other case, the device was discarded.Both incidents occurred at the same hospital, was reported by the same health care professional and occurred using product from the same lot.The returned device was tested and fulfilled specifications for both inspiratory and expiratory resistance.The patient valve was tested and all results are within the specification for the requirements from iso 10651-4.In the instructions for use, the following is described: always inspect the resuscitator and perform a functional test after unpacking, cleaning, assembly and prior to use.As part of the functional test, squeeze and release the resuscitator a few times to ensure that air is moving through the valve system and out of the patient valve.Always watch the movement of the chest and listen for the expiratory flow from the valve in order to check the ventilation efficiency.By adding accessories, it may increase inspiratory and/or expiratory resistance.Do not attach accessories if increased breathing resistance would be detrimental for the patient.

Event Description

During ventilation using the spur ii of two intubated patients, the expiration was obstructed.The user reported that the two patient was over-inflated, and that caused prolonged cardiopulmonary resuscitation for on one of the patients and massive circulatory insufficiency for the other patient.The two incidents occured the (b)(6) 2019.The over-inflation of the patient was detected and counteracted for.Patient outcome was not affected.

• 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: 12120106
• MDR Text Key: 260010133
• Report Number: 9610691-2020-00001
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 325023000
• Device Lot Number: 1000272525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: 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