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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DUODIAGNOST

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PHILIPS MEDICAL SYSTEMS DMC GMBH DUODIAGNOST Back to Search Results
Model Number 707015
Event Type  Malfunction  
Event Description

The customer complained that the foot rest of a duodiagnost tabletop was not completely locked up, so the pt almost lost his balance.

 
Manufacturer Narrative

The field service engineer checked for correct operation of foot support (footrest). The unit operated as expected. He could not find any sign of damage that may have contributed to support disengaging. The investigation showed the operator failed to check the correct locking of footrest into place, as required by the instructions for use. This is a user error. The instructions for use clearly warn the operator (danger!) that upon footrest mounting the correct locking must be checked, and describes how this is to be done. The customer was informed about the correct use of positioning and was retrained according to the instructions. No technical correction needs to be done because of no malfunction. The system works as specified. (b)(4).

 
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Brand NameDUODIAGNOST
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS DMC GMBH
roentgenstrasse 24
hamburg 2233 5
GERMANY 22335
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS DMC GMBH
roentgenstrasse 24
hamburg 2233 5
GERMANY 22335
Manufacturer Contact
dominic siewko
3000 minuteman rd
ms 4-135
andover , MA 01810
9786597936
MDR Report Key2581801
Report Number3003768251-2012-00012
Device Sequence Number1
Product CodeJAA
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 04/24/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number707015
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/15/2012
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 Initial

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