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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT EASY DIAGNOST ELEVA SYSTEM, X-RAY, STATIONARY

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PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT EASY DIAGNOST ELEVA SYSTEM, X-RAY, STATIONARY Back to Search Results
Device Problem Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2018
Event Type  malfunction  
Event Description
Per bio med, the collimator bulb in the x-ray machine keeps going out, lasts only three to four months, should last longer. Manufacturer response for light bulb, radiographic fluoroscopic system (per site reporter). Per bio med, manufacturer just sends out replacement bulbs to the facility.
 
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Brand NameEASY DIAGNOST ELEVA
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT
3000 minuteman road
andover MA 01810
MDR Report Key7994517
MDR Text Key124670989
Report Number7994517
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2018
Event Location Hospital
Date Report to Manufacturer10/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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