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

Catalog Number 530613025

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2021

Event Type  malfunction  

Manufacturer Narrative

Per customer feedback, spur ii was collapsed an unable to re-inflate to give adequate and appropriate ventilation.The same fault was identified for the back-up spur ii.Since no samples were returned for investigation and no lot numbers were provided, no function tests was performed as the samples were not available for investigation.Therefore analysis of production records was used to investigate the fault.The reported product was packed and controlled according to working instructions.Visual inspection was performed on the product during production and function test were performed during the production line.So, the reported product should be within specification when delivered.The reported issue of the bag being collapsed and unable to re-inflate is suspected to be due to storage or transportation of the product in a compressed state.However, due to limited information and no samples being available for investigation, the reported failure and root cause cannot be determined.As stated in the accompanying ifu, the resuscitator should never be stored in a deformed stated as permanent distortion of the bag may reduce the ventilation efficiency.The reported issue is easily identifiable during the prescribed precheck of the device prior to use on patient.

Event Description

During a narcotic overdose, spur ii was not able to provide adequate and appropriate ventilation, as the device was collapsed and unable to re-inflate.After identifying the problem a second crew arrived on the scene and attempted to use a another spur ii to provide ventilation, however the same fault were identified for the second spur ii.During the investigation, alberta health services confirmed that there were no adverse impact of the incident for the patient.While a single resuscitator with insufficient reinflation of the device does not pose a risk of serious health deterioration to the patient, as the failure to reinflate can be detected prior to use and resuscitation can be switched to back-up means of ventilation or to mouth-mouth ventilation, while a backup resuscitator is being readied, it is a more serious incident when the back-up device is also found to be affected by the same issue.When the backup device fails the patient is at risk of receiving insufficient ventilation over an extended time period (risk of hypoxia).The fault is easily detected during the prescribed pre-check.The accompanying ifu prescribes that functional test must always be performed before use of the resuscitator to ensure that the ambu bag can give sufficient ventilation.

• Brand Name: SPUR II PEDIATRIC BAG RESEVOIR
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, denmark 2750 ; DA 2750
• MDR Report Key: 12406192
• MDR Text Key: 270800878
• Report Number: 9610691-2021-00015
• 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,health professional,u
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530613025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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