MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. PINNACLE3 16.4 (ENG/FRA/DEU) SW; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

Model Number	16.4 PINNACLE3 ENG SW
Medical Device Problem Code	Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing investigation currently underway.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: complaint (b)(4).Date of report (b)(6) 2022.
Event or Problem Description
Dose exported to 3rd party systems is different than what is in pinnacle 16.4.3 this behavior was identified at a customer site after they submitted a treatment plan for inclusion in a trial.The treatment plan was rejected by the trial because it did not meet dose requirements.Upon further investigation the user discovered that the dose information exported out of pinnacle did not match the dose in the plan in pinnacle.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, 16.4.3 service pack 1.
Event or Problem Description
Dose exported to 3rd party systems is different than what is in pinnacle 16.4.3.This behavior was identified at a customer site after they submitted a treatment plan for inclusion in a trial.The treatment plan was rejected by the trial because it did not meet dose requirements.Upon further investigation the user discovered that the dose information exported out of pinnacle did not match the dose in the plan in pinnacle.

• Brand Name: PINNACLE3 16.4 (ENG/FRA/DEU) SW
• 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: 14875409
• Report Number: 3004022368-2022-00002
• Device Sequence Number: 5073803
• Product Code: MUJ
• UDI-Device Identifier: 00884838102965
• UDI-Public: 00884838102965
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 16.4 PINNACLE3 ENG SW
• Device Catalogue Number: 870231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown