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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH BUCKY DIAGNOST TH
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PHILIPS MEDICAL SYSTEMS DMC GMBH BUCKY DIAGNOST TH Back to Search Results
Model Number 704030
Device Problem Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Philips received a report from a customer that the external cassette holder (accessory) fell off the wall stand and struck the right foot of the radiographer at the metatarsal area.The skin was not broken and no treatment was required.
 
Manufacturer Narrative
The investigation showed that the lower spring-loaded catch was damaged and bent.The reason could not be definitely identified.The field service engineer was unable to repair the external cassette holder, he ordered and replaced it, this solved the problem.(b)(4).
 
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Brand Name
BUCKY DIAGNOST TH
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS DMC GMBH
roentgenstrasse 24
hamburg 2233 5
GM  22335
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND
roentgenstrasse 24
hamburg 2233 5
GM   22335
Manufacturer Contact
dominic siewko
3000 minutemand rd
ms 4-135
andover, MA 01810
9786597936
MDR Report Key3711981
MDR Text Key4251721
Report Number3003768251-2014-00001
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K945278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 12/17/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number704030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2014
Initial Date FDA Received01/15/2014
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
Patient Sequence Number1
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