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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH BUCKYDIAGNOST CEILING SYSTEM SYSTEM, X-RAY, STATIONARY

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PHILIPS MEDICAL SYSTEMS DMC GMBH BUCKYDIAGNOST CEILING SYSTEM SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number 704060
Device Problem Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still ongoing on this event. When the investigation is completed a follow-up report will be sent to the fda. (b)(4).
 
Event Description
The customer complained about a burned smell coming from the generator after switch on. Nobody was hurt.
 
Manufacturer Narrative
The bucky diagnost is a conventional x-ray system. The optimus generator (based in a metal covered rack) is a computer controlled converter x-ray generator to supply high tension to the x-ray tube. The philips healthcare field service engineer has investigated at site. The investigation showed that a thermal event occurred at one capacitor in the converter with the result of smoke emission. The optimus generator is ul (underwriters laboratories) listed and flame resistant and self-extinguishing.
 
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Brand NameBUCKYDIAGNOST CEILING SYSTEM
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS DMC GMBH
roentgenstr. 24
hamburg 22335
GM 22335
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
dusty leppert
roentgenstr. 24
hamburg 22335
GM   22335
405078-229
MDR Report Key6026071
MDR Text Key57619177
Report Number3003768251-2016-00008
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K945278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 09/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number704060
Device Catalogue Number704060
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/23/2016
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

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