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

Model Number	INGENIA 3.0T R5 BASED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial Hearing Loss (4472)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report of a patient who claimed to have sustained hearing loss following an mr examination.

• Brand Name: INGENIA 3.0T
• Common Device Name: INGENIA 3.0T
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• MDR Report Key: 12560572
• Report Number: 3003768277-2021-10156
• Device Sequence Number: 11086642
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: 884838055339
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 3.0T R5 BASED
• Device Catalogue Number: 781342
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 10/01/2021
• 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
• Patient Age: 47 YR
• Patient Weight: 69