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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EASYDIAGNOST ELEVA TABLE, RADIOGRAPHIC, TILTING

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PHILIPS MEDICAL SYSTEMS EASYDIAGNOST ELEVA TABLE, RADIOGRAPHIC, TILTING Back to Search Results
Device Problems Failure to Transmit Record (1521); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2019
Event Type  malfunction  
Event Description
This customer had a cystogram completed. There were several digital images taken during the fluoroscopy portion, and then an overhead x-ray after the procedure was completed. The technicians attempted to send the digital images to pacs. They were unable to get the digital images to transfer. After attempts made by a supervisor to resolve the issue to get the images to go (has been successful at times before), were unsuccessful, the supervisor contacted philips to assist. The representative made several attempts to resend the study, but the rep determined that the digital images were ultimately lost. There was the one overhead image that was sent to pacs and the radiologist was still able to provide a diagnosis. Biomedical engineering records: equipment passed preventative maintenance performed by philips on 3/18/19. Equipment passed medical physicist's fluoroscopy performance test summary on 5/16/19.
 
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Brand NameEASYDIAGNOST ELEVA
Type of DeviceTABLE, RADIOGRAPHIC, TILTING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
595 miner road
cleveland OH 44143
MDR Report Key9069615
MDR Text Key158630551
Report Number9069615
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2019
Device Age12 YR
Event Location Hospital
Date Report to Manufacturer09/16/2019
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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