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

Model Number 459801419351

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A follow up report will be submitted upon investigation completion.

Event 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.

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
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 5520 nobel drive, suite 125; fitchburg WI 53711
• MDR Report Key: 9120714
• MDR Text Key: 195585101
• Report Number: 3004022368-2019-00002
• Device Sequence Number: 1
• Product Code: MUJ
• UDI-Device Identifier: 00884838091122
• UDI-Public: (01)00884838091122
• Combination Product (y/n): N
• PMA/PMN Number: K170086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 459801419351
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1