Based on the available information, this event is deemed to be a reportable malfunction.The patient required oxygen therapy (o2) therapy.The device was removed/discontinued.There was no reported harm to the patient.Further information stated, "the complaints came in from various units throughout the city.These were the lots that we were able to identify from the stock that they were using on each ambulance." no additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.There are six cases associated with this product; therefore, five separate fda form 3500a have been generated to address the other cases.
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