MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS IMAGING LABORATORY GMBH ON-BOARD IMAGER (OBI); ACCELERATOR, LINEAR, MEDICAL

Model Number OBI

Device Problems Use of Incorrect Control/Treatment Settings (1126); Unintended Collision (1429); Malposition of Device (2616)

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

Event Date 09/14/2016

Event Type  malfunction  

Event Description

On board imager was being brought into position and went to a vertical coordinate of 2.3cm where it collided with the edge of the couch.The system is set so that the vertical cannot be less than 5cm.2.3cm is an invalid setting so unaware of how it could automatically move to this position.We were not able to reproduce this error.Manufacturer response for kv imaging detector, varian on board imaging (per site reporter).

• Brand Name: ON-BOARD IMAGER (OBI)
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS IMAGING LABORATORY GMBH; 3100 hansen way; palo alto CA 94304
• MDR Report Key: 6339174
• MDR Text Key: 67738390
• Report Number: 6339174
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OBI
• Other Device ID Number: 1.6
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2016
• Device Age: 10 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1