MAUDE Adverse Event Report: AMBU A/S AMBU SPUR II; MANUAL RESUSCITATOR, PRODUCT CODE: BTM

Catalog Number 520211000

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

The reported product was controlled in ambu production line and the functional tests were performed and passed.The product was within specifications when leaving the manufacturing site.The reported issue that the bag could not inflate can be due to a mechanical defect such as deformation due to improper storage or during transportation.The customer confirmed that he expected that storage or transportation issues had affected the product.However, as no sample was received the root cause could not be established.Additionally, as per stated in the ifu, a functional test of the device shall always be performed prior to use, in order to detect defects like this prior to use on a patient.The patient has been discharged from the hospital and back in her county of residence.Fda report reference number: mw5096666.

Event Description

The face mask (spur ii) would not inflate and therefore it was not able to provide rescue breathing to the patient.

• Brand Name: AMBU SPUR II
• Type of Device: MANUAL RESUSCITATOR, PRODUCT CODE: BTM
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 11848430
• MDR Text Key: 254669491
• Report Number: 9610691-2020-00011
• 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: other
• Type of Report: Initial
• Report Date: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 520211000
• Device Lot Number: 16 73030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention