FDA 483 - Dartmouth Hitchcock Medical Center - December 17, 2015

The FDA Form 483 documents observations from an inspection of a user facility, identifying deficiencies in their Medical Device Reporting (MDR) procedures and practices.

The facility's Medical Equipment Management Plan (MEMP) policies (Policy 4, 12/15/98-10/28/14, and Policy ID: 6012, 10/28/14-present) were found inadequate for timely and effective identification, communication, and evaluation of events subject to MDR requirements. The Department of Risk Management and Clinical Engineering are responsible for submitting MDR events to FDA via MedSun. The Risk Manager confirmed these are the only policies for MDR submission.

The facility failed to submit FDA Form 3500A or electronic equivalents to the device manufacturer within 10 working days of becoming aware of information suggesting a device caused or contributed to a serious injury. Specifically, an event on or about [redacted date] involving a [redacted device] used for a [redacted procedure] resulted in a surgical intervention due to the [redacted side] facing the inside of the vessel. This serious injury event was not submitted to FDA via MedSun. Another event on [redacted date] involved a patient on a [redacted device] that did not [redacted function] (Patient Safety Event ID: [redacted]), also not submitted to FDA/manufacturer via MedSun.

Furthermore, MDR event