The reported product was discarded., therefore, no sample, nor picture was available for investigation.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 testing 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 detected during functional testing.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 that might 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 being 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.
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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.
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