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

Model Number 520211010

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Cardiac Arrest (1762)

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

Unfortunately, no sample nor picture was available for investigation since the reported product was discarded.Thus, the reported failure could not be verified.According to the customer complaint, the affected spur ii was used to confirm a proper placement of an endotracheal tube and after the third attempt of placing endotracheal tube, they realized that the spur ii malfunctioned.The second spur ii functioned well and patient's saturation rose.This was followed by a cardiac arrest, compressions and once the spontaneous circulation was achieved, the patient was placed on a ventilator.After the incident, the customer inspected the product and noticed a sizeable tear in the compressible bag at one of the seams.The accompanying ifu prescribes that functional test after unpacking, assembly and prior to use, such as inspiratory/ expiratory test, reservoir bag test and high/ low pressure test must always be performed to ensure that the ambu bag can give sufficient ventilation.If there is a sizable tear on product, the tear in the inflation bag should be easily detectable during functional test.All spur ii will have a functional test performed before packaging according to work instructions.A sizeable tear could not go undetected.This is the first complaint about a tear on the compressible bag in the past one year.There are some possibilities to cause a tear on the compressible bag, such as cut by a sharp object, reprocessing, improper handling during unfolding the compressible bag or compressible bag not installed well with patient valve housing or inlet-valve housing.Due to no sample, no picture and limited information, the root cause could not be determined.

Event Description

Patient was intubated.End-tidal carbon dioxide (etco2) cap was placed and activated via an ambu a/s spur ii adult resuscitator bag to confirm proper placement of endotracheal tube (eet).Etco2 did not show color change.Ett was immediately removed and replaced.After the 3rd attempt of failed etco2 color change, via ambu bag, ambu bag was replaced.Positive color change was achieved and patients sats began to rise.Pulse was lost and compressions where initiated.Upon return of spontaneous circulation (rosc), patient was placed on ventilator.- after inspection of the ambu bag, it was noticed that there was a sizable tear on the inflation bag at one of the seams.

• 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: 17681034
• MDR Text Key: 322605328
• Report Number: 9610691-2023-00020
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 520211010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 0300640000-2023-8010
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening