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
The investigation is still in progress.A follow up report will be submitted upon investigation completion.
Event or Problem Description
Pinnacle computes the dose at 131 degrees and 90 degrees, and nothing in between.Half of cp 17¿s dose is at 131, and the other half is at 90, and nothing in between is included.The dose is not spread out between 131 and 90.
Additional Manufacturer Narrative
Investigation of the issue determined this is 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.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 2 reported complaints of this issue out of 535 sites that have the involved software versions and no reports of patient harm.One of these 2 complaints was noted to have crashed, which does not generate a completed treatment plan.Therefore, only 1 complaint in 535 number of sites is used to determine the probability of the situation causing harm.It is the belief of the clinicians involved in this assessment that this risk is acceptable.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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: 9120714
• Report Number: 3004022368-2019-00002
• Device Sequence Number: 2132191
• Product Code: MUJ
• UDI-Device Identifier: 00884838091122
• UDI-Public: (01)00884838091122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 08/27/2019

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
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1