MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 16.2.1 PINNACLE3 SW; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	459801419351
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No new investigation was completed for this complaint as this malfunction was previously investigated and reported by emdr 3004022368_2019_00002.The issue has been determined to be a software defect.This issue is caused by the invalidation of only the last control point, instead of invalidating the entire beam, when only the stop angle of valid conformal arcs in the beam spread sheet is edited.A fix for this issue has already been implemented in the current software release, pinnacle software version 16.4.2.However, the issue would be identified during a review of the plan and secondary quality assurance checks in accordance with standard care prior to initiating treatment.There have only been 4 reported complaints of this issue out of approximately 540 sites that have the involved software versions and no reports of patient harm.
Event or Problem Description
The customer was attempting to save a conformal arc plan however the pinnacle software would crash after each attempt.There was no patient impact as the inability to save the plan would prevent the plan from being used.A remote-in session and review of plan logs revealed a failed assertion in the software for one of the control points.Philips has determined this to be a known issue that can occur when the gantry stop angle is changed in the beam spreadsheet, where the machine limits are not checked.

• Brand Name: 16.2.1 PINNACLE3 SW
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 5520 nobel drive, suite 125; fitchburg WI 53711
• MDR Report Key: 10406848
• Report Number: 3004022368-2020-00002
• Device Sequence Number: 2327396
• Product Code: MUJ
• UDI-Device Identifier: 00884838091122
• UDI-Public: (01)00884838091122(10)16.2.1.60098
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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: 459801419351
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1