EASYDIAGNOST ELEVA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for EASYDIAGNOST ELEVA manufactured by .

Event Text Entries

[144105279] Fluoroscopy unit stopped working during procedure. Fda safety report id# (b)(4). See scanned pages.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086346
MDR Report Key8574013
Date Received2019-05-01
Date of Report2019-04-29
Date of Event2019-04-24
Date Added to Maude2019-05-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameEASYDIAGNOST ELEVA
Generic NameSYSTEM, X-RAY, FLUOROSCOPIC, IMAGE - INTENSIFIED
Product CodeJAA
Date Received2019-05-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0

Device Sequence Number: 1

Brand NameEASYDIAGNOST ELEVA
Generic NameSYSTEM, X-RAY, FLUOROSCOPIC, IMAGE - INTENSIFIED
Product CodeJAA
Date Received2019-05-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPHILLIPS


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-01

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