FDA 483 - Ucla Medical Ctr - December 18, 2015

This FDA Form 483 document details observations from an inspection of a user facility. The facility failed to provide all reasonably known information concerning individual adverse event reports, including details from documents in its possession. Specifically, a medical device complaint submitted under MAUDE (Report Number: redacted) involved a total of redacted patients, but the facility did not file separately each of the redacted additional individual adverse events.

Furthermore, the user facility did not submit FDA Form 3500A or its electronic equivalent to the known device manufacturer within 10 working days of becoming aware of information reasonably suggesting a device caused or contributed to a serious injury. An example cited is a MedSun Report (Report Name: redacted), dated redacted with an event date of redacted, which involved a device malfunction that necessitated an intervention to prevent permanent impairment or damage to the patient. This report was not submitted within the required timeframes. These observations indicate deficiencies in the facility's adverse event reporting procedures and compliance with regulatory timelines.