MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 16.2 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
Event or Problem Description
On august 2, 2018 we received a complaint, from (b)(6) medical center, stating that the couch removal plan moves from the position selected by the user.The customer alleged this is to be a safety issue.This situation was determined to be the same as pinn00027109 (a known non-safety related defect from a complaint made by (b)(6) cancer center on (b)(6) 2017).Based on the allegation of a safety issue by uh cleveland medical center and recommendation of philips application support engineers, a special defect management committee meeting was held to discuss defect pinn00027109 (a known defect from a complaint made by (b)(6) cancer center on (b)(6) 2017).During this meeting, based on new information, from the uh cleveland medical center complaint call and investigation it was decided that the defect severity should be changed from severity 4 to severity 3.In this instance, the severity 3 is a safety-related severity 3; this is not a severity 3 due to a lack of a work-around.

• 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: 7839397
• Report Number: 3004022368-2018-00003
• Device Sequence Number: 1271839
• Product Code: MUJ
• UDI-Device Identifier: 00884838091122
• UDI-Public: (01)00884838091122(10)16.2.0.60010
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2018

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: 08/02/2018
• Supplement Date Received by Manufacturer: 08/02/2018; 08/02/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/30/2018; 10/30/2018
• 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