MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. PINNACLE3 SMART ENTERPRISE SERVER; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

Model Number	PINNACLE3 SMART ENTERPRISE SERVER
Medical Device Problem Code	Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing investigation currently underway.Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: (b)(4).Date of report 20220629.
Event or Problem Description
Exported dose from a plan is wrong when imported back into pinnacle and when exporting to 3rd party systems.This behavior was identified by the customer while doing dose comparison testing between software version 18.0.1 and software version 9.8.After exporting plans to 3rd party system mim it was discovered that the dose was different between the two plans.This issue is currently under investigation by the manufacturer.
Additional Manufacturer Narrative
Manufacturer¿s investigation has identified a specific coding issue that was introduced in the development phase of pinnacle software version 16.4.2 as the root cause of this issue.This coding issue has been corrected and this fix is being distributed to the customer via installation of a service pack, specifically in this case, 18.0.1 service pack 1.Internal cross reference: complaint pr# (b)(4).Date of report 20220916.
Event or Problem Description
Exported dose from a plan is wrong when imported back into pinnacle and when exporting to 3rd party systems.This behavior was identified by the customer while doing dose comparison testing between software version 18.0.1 and software version 9.8.After exporting plans to 3rd party system mim it was discovered that the dose was different between the two plans.

• Brand Name: PINNACLE3 SMART ENTERPRISE SERVER
• 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: marcus palmer ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 14875278
• Report Number: 3004022368-2022-00004
• Device Sequence Number: 17429595
• Product Code: MUJ
• UDI-Device Identifier: 00884838103566
• UDI-Public: 00884838103566
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: PINNACLE3 SMART ENTERPRISE SERVER
• Device Catalogue Number: 870192
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown