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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST SINGLE DETECTOR SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Model Number 712020
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The customer complained that the brake cylinder broke out of the frame of the patient support for stitching. The brake cylinder prevents the footboard of the patient support for stitching from falling down unexpected. A falling footboard can lead in worst case to a fracture in the foot. No injury occurred.
 
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.
 
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Brand NameDIGITALDIAGNOST SINGLE DETECTOR
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 Key13257993
MDR Text Key286668057
Report Number3003768251-2022-00001
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K090625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number712020
Device Catalogue Number712020
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/21/2021
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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