MAUDE Adverse Event Report: ACCURAY INCORPORATED ACCURAY TOMOTHERAPY HI-ART SYSTEM; TOMOTHERAPY TREATMENT SYSTEM

Model Number H-0000-0003

Device Problems Component Falling (1105); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

A complaint was recently received for a problem involving an unexpected treatment couch descent.The couch fell approximately 2.0 cm.There was no injury to the patient or staff.We are currently investigating the root cause and possible preventive/corrective actions.

Event Description

A complaint was recently received for a problem involving an unexpected treatment couch descent.The couch fell approximately 2.0 cm.There was no injury to the patient or staff.

• Brand Name: ACCURAY TOMOTHERAPY HI-ART SYSTEM
• Type of Device: TOMOTHERAPY TREATMENT SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1310 chesapeake terrace; sunnyvale CA 94089
• Manufacturer (Section G): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: matthew vandervoort ; 1310 chesapeake terrace; sunnyvale, CA 94089 ; 4087164666
• MDR Report Key: 6324570
• MDR Text Key: 67490549
• Report Number: 3003873069-2017-00005
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: M6581043090
• UDI-Public: M6581043090
• Combination Product (y/n): N
• PMA/PMN Number: K121934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H-0000-0003
• Device Catalogue Number: H-0000-0003
• Device Lot Number: N/A
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1