MAUDE Adverse Event Report: AMBU A/S AMBU SPUR II PEDIATRIC BAG RESUSCITATOR; SINGLE-USE RESUSCITATOR

Catalog Number 530612010

Device Problems Kinked (1339); Defective Device (2588); Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

The affected resuscitator was not received for investigation, neither was a picture provided.Contacted customer several times to obtain more information about the incident, customer is not responding.Product was manufactured and tested according to working procedure.High/low pressure test, inspiratory resistance test, valve function test, reservoir bag test and spontaneous breathing test were performed according to work instructions to ensure the product can meet the product specifications.Due to limited information, it is difficult to verify the reported failure and the root cause of the reported failure cannot be identified.Spur ii resuscitator is designed for use by cpr-trained personnel only, and information for safety provided in accompanying document (ifu) inform that a functional test must always be performed after unpacking, cleaning, assembly and prior to use.No causal relationship has been established between reported failure and patient outcome.Device was not returned for evaluation.

Event Description

Resuscitator used on pediatric patient in recovery after anesthesia.According to medwatch report the resuscitator did not allow for free flow of oxygen.The connector between the tubing and bag was kinked and appeared to have been a manufacturer defect.It appeared to have been melted within the package.

• Brand Name: AMBU SPUR II PEDIATRIC BAG RESUSCITATOR
• Type of Device: SINGLE-USE RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup 2750, ballerup 2750, dk ; DA
• Manufacturer (Section G): AMBU A/S; baltorpbakken 13,; 2750 ballerup, dk-2750 ; DA
• Manufacturer Contact: sanjay parikh ; 6230 old dobbin lane; suite 250; columbia, MD 21045 ; 4107686464
• MDR Report Key: 5723923
• MDR Text Key: 47362959
• Report Number: 9610691-2016-00002
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K042843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 530612010
• Device Lot Number: 10007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 30