MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 16.2 PINNACLE3 SW; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	459801419351
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
The wedge id is not exported via dicom unless manufacture code is populated in physics (300a,00d4).Initial investigation resulted in the realization that there was no manufacture code for the edw wedge in physics.This resulted in no wedge id being exported via dicom to the r&v system.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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 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: 8100110
• Report Number: 3004022368-2018-00005
• Device Sequence Number: 19414500
• Product Code: MUJ
• UDI-Device Identifier: 00884838091122
• UDI-Public: (01)00884838091122(10)16.2.0.60010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 10/24/2018

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: 459801419351
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018; 10/24/2018
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 01/14/2019; 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other