MAUDE Adverse Event Report: AMBU A/S AMBU SPUR II ADULT BAG RES.

Model Number 520611000

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 05/22/2023

Event Type  Death  

Event Description

Patient was admitted for fluid overload.Patient was hyperkalemic and was receiving hemodialysis when they became unresponsive.Nurse checked and patient was pulseless.Cpr was initiated.Patient experienced cardiopulmonary arrest and demonstrated pulseless electrical activity on monitor during pulse check.Resuscitation was initiated and the patient was bagged.Staff member noted that the ambu bag in use was not inflating and a tear was found in the bag.Another ambu bag was obtained so that resuscitation efforts could continue.Additional information provided by the customer revealed that the patient expired.

Manufacturer Narrative

Resuscitation of the patient was initiated after cardiopulmonary arrest and the spur ii was found not to be inflating due to a tear.A backup spur ii was retrieved to continue the resuscitation.Follow-up with the customer revealed that the patient expired.During the manufacturing process all the resuscitators undergo a function test, consisting of an inspiratory/expiratory test, reservoir bag test and high/low pressure test, in order to verify that the finished products meet the design specifications.A tear on a product would have been detected during these tests, which take place prior to packing.Since there was no sample nor picture available for investigation, the reported failure could not be verified and we can only speculate on the position of the tear.The tear could have been on a compressible bag or reservoir bag and in both cases such tear could be a result of reprocessing or cutting through the wall by a sharp object.Additionally, by pulling onto the reservoir bag or the bag not welding well could result in the tear as well.We can only exclude reprocessing and reuse from the listed potential causes based on the limited information, thus the root cause could not be determined.The accompanying instructions for use state 'always inspect the resuscitators and perform functional test after unpacking, cleaning, assembly and prior to use'.Tear in the compressible or reservoir bags is detectable during pre-check.This is the second complaint within the past 12 months.The root cause is unknown, however we will keep monitoring the occurrence of similar incidents.

• Brand Name: AMBU SPUR II ADULT BAG RES.
• Type of Device: AMBU SPUR II ADULT BAG RES.
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU LTD.; warehouse & process complex; building, no.c, xiang yu f.t.z; xiamen, 36100 6; CH 361006
• Manufacturer Contact: lenka vaculciakova ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 18100404
• MDR Text Key: 327715569
• Report Number: 9610691-2023-00025
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 520611000
• Device Catalogue Number: 520611000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2023
• 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): Death