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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH EASYDIAGNOST ELEVA DRF SYSTEM, X-RAY, STATIONARY

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PHILIPS MEDICAL SYSTEMS DMC GMBH EASYDIAGNOST ELEVA DRF SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number 706034
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Int. Ref. : (b)(4). The easydiagnost eleva is a nearby controlled r/f (radiography /fluoroscopy) system designed to perform a wide range of applications from gastrointestinal, various iodine and vascular procedures to standard radiography. A foot rest is provided to help support the patient during table tilting. The philips healthcare field service engineer has investigated at site and confirmed that the footrest was not locking on left side due to a defect catch. The event was originally reported to the authorities as not enough information was available to make a definite reportability decision. Since that time, additional information was received which revealed that the event does not meet the criteria for 21 cfr 803.
 
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.
 
Event Description
The customer has complained that the table top foot rest of the easydiagnost eleva did not lock anymore on the left side. No one was injured.
 
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Brand NameEASYDIAGNOST ELEVA DRF
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 Key6352308
MDR Text Key261075197
Report Number3003768251-2017-00001
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031535
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup
Report Date 01/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number706034
Device Catalogue Number706034
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/25/2017
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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