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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH BUCKYDIAGNOST CEILING SYSTEM (CS)

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PHILIPS MEDICAL SYSTEMS DMC GMBH BUCKYDIAGNOST CEILING SYSTEM (CS) Back to Search Results
Model Number 704031
Device Problems Unintended System Motion (1430); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 reported that the board of patient support cannot be fixed. No injury reported.
 
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Brand NameBUCKYDIAGNOST CEILING SYSTEM (CS)
Type of DeviceBUCKYDIAGNOST CEILING SYSTEM (CS)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS DMC GMBH
roentgenstrasse 24
hamburg 22335
GM 22335
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS DMC GMBH
roentgenstrasse 24
hamburg 22335
GM 22335
Manufacturer Contact
dusty leppert
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key12802282
MDR Text Key280705521
Report Number3003768251-2021-10014
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K945278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number704031
Device Catalogue Number704031
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received10/13/2021
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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