MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA ELITION X

Model Number	INGENIA ELITION X
Medical Device Problem Codes	Electrical Overstress (2924); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a report that an ingenia elition mr system caught fire during a test scan.
Event or Problem Description
On (b)(4) 2022 philips was notified of a fire in the herlev hospital in the capital region denmark.The incident did not cause harm to patients, operators, service personnel, bystanders or the environment, but caused severe property damage.The philips ingenia elition x system (model number [781358] and serial number (b)(6) was irreparably damaged.

• Brand Name: INGENIA ELITION X
• Common Device Name: INGENIA ELITION X
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14016102
• Report Number: 3003768277-2022-00145
• Device Sequence Number: 4698564
• Product Code: LNH
• UDI-Device Identifier: 00884838088115
• UDI-Public: 884838088115
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K173356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• 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 ELITION X
• Device Catalogue Number: 781358
• 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: 04/01/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 10/13/2022
• 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