MAUDE Adverse Event Report: PHILIPS HEALTHCARE INGENIA 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 781341

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

Patient Problem Hearing Impairment (1881)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up will be sent to the fda.

Event Description

Philips received a report from a customer related to a patient who complained of a hearing problem after an mr examination on an ingenia 1.5t system.

Manufacturer Narrative

The actual acoustic noise level that is produced by an mri system depends on the type of mr, the configuration and the used scan protocols (examcard).Also the local situation may have influence on this level.The used examcard and logfiles were therefore requested to determine the actual acoustic noise produced on the mr system.However, no logfiles or examcard were provided, therefore no further investigation can be performed by the biu.As a result, we cannot answer the customer's question about the actual acoustic noise level.It was stated that the patient refused to wear any hearing protection.No further information was provided whether the alleged hearing damage/loss was confirmed by a hearing test.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INGENIA 1.5T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8178738
• MDR Text Key: 130791865
• Report Number: 3003768277-2018-00097
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K110151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 781341
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other