MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. PINNACLE 18.0; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

Model Number	PINNACLE 18.0
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During internal testing an issue was found in which the advanced region of interest (roi) expansion tool expands rois incorrectly on headfirst prone (hfp), feet first supine (ffs), and feet first prone (ffp) datasets.There is no allegation of a death or serious injury.A defect was filed and has been evaluated by the defect review board (drb) and scored as an unacceptable safety defect.An issue impact assessment (iia) has been triggered and philips is investigating the issue.
Additional Manufacturer Narrative
The investigation into this issue is ongoing.Philips will provide another report in 30 days.
Additional Manufacturer Narrative
Investigation of the issue determined this is a software defect.The cause of this issue is that all of the advanced roi (region of interest) expansion/contraction directions are hardcoded the same as hfs (head first supine) and not adjusted according to different patient orientations hfp, ffs and ffp (head first prone, feet first supine, feet first prone).The issue was discovered during internal testing of the software.There are no reports of this issue from the field.

• Brand Name: PINNACLE 18.0
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 100 park avenue, suite 300; orange village OH 44122
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 100 park avenue, suite 300; orange village OH 44122
• Manufacturer Contact: kenneth revennaugh ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 20481113
• Report Number: 3004022368-2024-00003
• Device Sequence Number: 8266820
• Product Code: MUJ
• UDI-Device Identifier: 00884838103566
• UDI-Public: 00884838103566
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2024

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
• Device Model Number: PINNACLE 18.0
• Device Catalogue Number: 870237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: Not provided; 10/09/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/13/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown