MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA 3.0T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA 3.0T R5 BASED
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the table floor plate for the mri was incorrectly installed.It was identified that the table floor plate was glued into the timber floor instead of through bolted and anchored to the concrete structural floor.There is potential for the table to become dislodged from the base and allowing for movement or tipping of the table.Based on the available information, this event is determined to be reportable.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips was informed that a patient support of an mr system became dislodged from its base on the floor.It was discovered that a number of mr patient supports, 5 in total, were incorrectly installed in australia by external contractor, acept.Specifically, the patient supports were installed to the floorboards using a chemical adhesive substance, instead of the mechanical fixation as according to philips prds (planning reference data).Dislodging of the patient supports from their base could lead to unwanted table movement or tipping which can inadvertently lead to patient injury under certain circumstances.The investigation concluded that a number of mr patient supports were incorrectly installed in australia by external contractor acept, the root cause determined is that the instructions outlined in philips prds were not followed.Action in the field will be conducted to address this issue for the 5 affected sites in australia.

• Brand Name: INGENIA 3.0T
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16569246
• Report Number: 3003768277-2023-01771
• Device Sequence Number: 6138788
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: 884838055339
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K163116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup

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: INGENIA 3.0T R5 BASED
• Device Catalogue Number: 781342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown