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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 1.5T INGENIA 1.5T R5 BASED

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PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 1.5T INGENIA 1.5T R5 BASED Back to Search Results
Model Number 781341
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Patient Involvement (2645)
Event Date 07/03/2020
Event Type  malfunction  
Event Description
Philips received a report on a fire in the hospital which damaged the mr system.
 
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Brand NameINGENIA 1.5T
Type of DeviceINGENIA 1.5T R5 BASED
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
veenpluis 6
best 5684 -PC
NL   5684 PC
MDR Report Key10244162
MDR Text Key198330908
Report Number3003768277-2020-01004
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K163116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number781341
Device Catalogue Number781341
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/03/2020
Event Location No Information
Date Manufacturer Received07/03/2020
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 Treatment Data
Date Received: 07/08/2020 Patient Sequence Number: 1
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