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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
Medical Device Problem Code Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code Partial thickness (Second Degree) Burn (2694)
Date of Event 07/09/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Philips received a report on a heating incident on an ingenia 1.5t mr system.A patient suffered 2nd degree burns on both thumbs and both thighs.
 
Event or Problem Description
Philips received a report on a heating incident on an ingenia 1.5t mr system.A patient suffered 2nd degree burns on both thumbs and both thighs.
 
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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 Key12286538
Report Number3003768277-2021-10039
Device Sequence Number11722434
Product Code LNH
UDI-Device Identifier00884838009820
UDI-Public884838009820
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K110151
Number of Events Summarized1
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,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
Device Catalogue Number781396
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date07/19/2021
Initial Date Received by Manufacturer 07/12/2021
Supplement Date Received by Manufacturer07/12/2021
Initial Report FDA Received Date08/06/2021
Supplement Report FDA Received Date09/28/2021
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 Age65 YR
Patient Weight75
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