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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST DUAL DETECTOR SOLID STATE X RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Model Number 712022
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
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 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.
 
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Brand NameDIGITALDIAGNOST DUAL 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
roentgenstrasse 24
hamburg 22335
GM   22335
40349710
MDR Report Key10301542
MDR Text Key199703959
Report Number3003768251-2020-01000
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K090625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number712022
Device Catalogue Number712022
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/07/2020
Event Location No Information
Date Manufacturer Received07/07/2020
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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