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

Model Number 459801419351

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  malfunction  

Event 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.

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.

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
• 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: 8100110
• MDR Text Key: 128585859
• Report Number: 3004022368-2018-00005
• Device Sequence Number: 1
• Product Code: MUJ
• UDI-Device Identifier: 00884838091122
• UDI-Public: (01)00884838091122(10)16.2.0.60010
• 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,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• 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
• Date Manufacturer Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other