MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA 1.5T R5 BASED
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that a technician received an electric shock during installation activities.The technician was temporarily hospitalized.Philips has started an investigation of this complaint a follow up will be sent once an investigation is completed.
Additional Manufacturer Narrative
The reported issue was investigated.It was concluded that it was a manufacturing issue during e-box assembling.The screw which fixes the electrical panel on the back of e-box damaged the internal mains cable, which in turn caused the insulation skin of the cable to be damaged.This is the first time this type of malfunction has been reported regarding this part.The supplier performed a check of the stock and items in production and no further cases were found.

• Brand Name: INGENIA 1.5T
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• 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: 15886278
• Report Number: 3003768277-2022-01267
• Device Sequence Number: 20074980
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: 884838055322
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: INGENIA 1.5T R5 BASED
• Device Catalogue Number: 781341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown