ACHIEVA 1.5T NEW 781296

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-25 for ACHIEVA 1.5T NEW 781296 manufactured by Philips Electronics Nederland B.v..

Event Text Entries

[184276118] Magnet quench after a fire in the vicinity of the examination room.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003768277-2020-01001
MDR Report Key9749763
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-25
Date of Event2020-01-22
Date Facility Aware2020-01-26
Date Mfgr Received2020-01-26
Date Added to Maude2020-02-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DUSTY LEPPERT
Manufacturer StreetVEENPLUIS 6
Manufacturer CityBEST 5684PC
Manufacturer CountryNL
Manufacturer Postal5684 PC
Manufacturer G1PHILIPS ELECTRONICS NEDERLAND B.V.
Manufacturer StreetVEENPLUIS 6
Manufacturer CityBEST 5684PC
Manufacturer CountryNL
Manufacturer Postal Code5684 PC
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACHIEVA 1.5T NEW
Generic NameACHIEVA 1.5T NEW
Product CodeLNH
Date Received2020-02-25
Model NumberACHIEVA 1.5T
Catalog Number781296
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS ELECTRONICS NEDERLAND B.V.
Manufacturer AddressVEENPLUIS 6 BEST 5684PC NL 5684 PC


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-25

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