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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS DMC GMBH BUCKY DIAGNOST SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number BUCKY DIAGNOST FS S
Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 09/18/2020
Event Type  malfunction  
Event Description
Table bucky was not sensing any cassettes. There was no auto collimation possible. Error code (cassette not centric) problem did not resolve with restarting equipment. Error code persists even with 14x17 cassette. Had to retake test and there was a delay in treatment.
 
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Brand NameBUCKY DIAGNOST
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS DMC GMBH
100 park avenue
suite 300
orange village OH 44122
MDR Report Key10860124
MDR Text Key216866051
Report Number10860124
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 Other Health Care Professional
Type of Report Initial
Report Date 09/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBUCKY DIAGNOST FS S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2020
Device Age10 YR
Event Location Hospital
Date Report to Manufacturer11/18/2020
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 Unkown

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