MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA 3.0T

Model Number	INGENIA 3.0T R5 BASED
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.
Event or Problem Description
It was reported that the system arrived on site for installation with the incorrect lifting bolts attached.These incorrect lifting bolts were rated for a 1.5t system but not for a 3.0t system.There was no harm as a result of this event.If this issue were to recur and inadequately rated lifting bolts were used during an installation and would fail, there would be potential for serious injury or death.Therefore, this event is determined to be reportable.A follow up report will be submitted after the investigation has been completed.
Additional Manufacturer Narrative
The issue concerns the use of inadequately rated lifting lugs.This issue was discovered end of 2019 and subsequently fixed for initial systems.The complaint at hand concerns the same issue, but not on an initial system but on a refurbished system.The root cause is that the solution defined for initial systems was not properly deployed to other use cases, including refurbished systems.An indepth investigation was also perfomed together with the supplier of the bolts to determine if there was a risk associated with the use of the incorrect lugs of which the following is the conclusion: review of lifting lug test rud m20 starpoint (ref-3) indicated that the lug is safe to use for use on mr products and it meets all the applicable regulatory standards and requirements.

• Brand Name: INGENIA 3.0T
• Common Device Name: INGENIA 3.0T
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16549201
• Report Number: 3003768277-2023-01611
• Device Sequence Number: 5993470
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: 884838055339
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: Other
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown