Based on the available info, this event is deemed to be a reportable malfunction.It was further reported of two (2) similar incidents had occurred in the 2 days previously.Oxygen tubing and face mask were immediately reconnected and staff nurse on ward was informed.Staff nurse reported, she was already aware of the problem and that the patient was pulling at the oxygen tubing however, this was not witnessed by the physician.No additional info has been provided to date.Should additional info become available, a follow-up report will be submitted.Reported to fda on 10/21/2014, manufacturing site: (b)(4).Note: there are two cases associated with this product, one for the mask and one for the tubing; this case is to address the mask.An additional fda form 3500a has been generated to address the tubing.
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