Based on the available information, this event is deemed to be both a reportable malfunction and a serious injury.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on: november 01, 2016.(b)(4).Note: this complaint issue occurred in three (3) cases.A separate 3500a form has been prepared for the other two (2) associated cases.
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Complaint received reporting that the device cuff did not seal (inflate) and re-inflation was required every hour to maintain proper cuff pressure for an emergency intubation of a three (3) month old patient.The device was removed and a new one inserted.The cuff on the second device also did not seal (inflate).Metal clamps were attached to the pilot tube to stabilize the airway cuff pressure.The second device was removed and a third device was inserted.The physician stated that this is not the first time this issue has occurred.However, it is unknown how many devices were affected.The patient's condition was critical during the event, but it could not be confirmed that the patient's condition worsened due to the reported event.It was reported that the patient required suction to clear aspirated fluid.It was also reported that the patient is stabilized and is recovering from aspiration pneumonia.The device is no longer available and was discarded.No further information has been provided.
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