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

Model Number INGENIA 3.0T R5 BASED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial Hearing Loss (4472)

Event Date 08/12/2021

Event Type  Injury  

Event Description

Philips received a report of a patient who claimed to have sustained hearing loss following an mr examination.

• Brand Name: INGENIA 3.0T
• Type of Device: INGENIA 3.0T
• 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: 12560572
• MDR Text Key: 274219695
• Report Number: 3003768277-2021-10156
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: 884838055339
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K163116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 69