Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Additional patient/event details have been requested.Should additional information become available, a follow-up report will be submitted.This complaint involves one known device and an unknown number of devices with the same complaint; therefore one fda 3500a will be submitted for the known device and one fda 3500a for the unknown number of devices.
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