MAUDE Adverse Event Report: ACCURAY INCORPORATED ACCURAY TOMO HD SYSTEM; TOMOTHERAPY TREATMENT SYSTEM

Model Number	H-0000-0003
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was recently received for a problem involving an unexpected treatment couch descent.The couch fell approximately 57 mm (~2.25 inches).There was no injury to the patient or staff.We are currently investigating the root cause and possible preventive actions.
Event or Problem Description
A complaint was recently received for a problem involving an unexpected treatment couch descent.The couch fell approximately 57 mm (~2.25 inches).There was no injury to the patient or staff.

• Brand Name: ACCURAY TOMO HD SYSTEM
• Common Device Name: TOMOTHERAPY TREATMENT SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1310 chesapeake terrace; sunnyvale CA 94089
• MDR Report Key: 6233853
• Report Number: 3003873069-2017-00001
• Device Sequence Number: 1477984
• Product Code: IYE
• UDI-Device Identifier: M6581043090
• UDI-Public: M6581043090
• Combination Product (Y/N): N
• PMA/510(K) Number: K121934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H-0000-0003
• Device Catalogue Number: H-0000-0003
• Device Lot Number: N/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1