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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 1.5T
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PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 1.5T Back to Search Results
Model Number INGENIA 1.5T R5 BASED
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes Hearing Impairment (1881); Partial Hearing Loss (4472)
Date of Event 12/15/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Philips received a report that a patient allegedly suffered a permanent hearing loss/ tinnitus after an examination on an ingenia 1.5t mr system.
 
Event or Problem Description
Philips received a report that a patient allegedly suffered a permanent hearing loss/tinnitus after an examination on an ingenia 1.5t mr system.
 
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Brand Name
INGENIA 1.5T
Common Device Name
INGENIA 1.5T
Manufacturer (Section D)
PHILIPS ELECTRONICS NEDERLAND B.V.
veenpluis 6
best 5684 PC
NL  5684 PC
MDR Report Key11027086
Report Number3003768277-2020-01037
Device Sequence Number3562579
Product Code LNH
UDI-Device Identifier00884838055322
UDI-Public884838055322
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K163116
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
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 NumberINGENIA 1.5T R5 BASED
Device Catalogue Number781341
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date11/23/2020
Initial Date Received by Manufacturer 11/23/2020
Supplement Date Received by Manufacturer11/23/2020
Initial Report FDA Received Date12/17/2020
Supplement Report FDA Received Date02/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age27 YR
Patient Weight60
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