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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST C90 HIGHPERFORMANCE SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

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PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST C90 HIGHPERFORMANCE SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Model Number 712034
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Ref. Id: (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 tilting patient platform on the patient support for stitching drops to the floor too fast. No injury reported.
 
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Brand NameDIGITALDIAGNOST C90 HIGHPERFORMANCE
Type of DeviceSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
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 Key14168904
MDR Text Key289776511
Report Number3003768251-2022-00004
Device Sequence Number1
Product Code MQB
UDI-Device Identifier00884838090699
UDI-Public00884838090699
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K182973
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number712034
Device Catalogue Number712034
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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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