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
An evaluation of this event determined the presence of a non-functional software defect.A fix for this issue is planned for a future software release.
Event or Problem Description
A customer contacted philips to advise that a user error caused inaccurate treatment doses to be administered to a patient.There was no injury associated with this 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: 9219170
• Report Number: 3004022368-2019-00003
• Device Sequence Number: 11570986
• Product Code: MUJ
• UDI-Device Identifier: 00884838091122
• UDI-Public: (01)00884838091122
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1