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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 3.1.X SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

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PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 3.1.X SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Model Number 712026
Device Problem Device Fell (4014)
Patient Problems Abrasion (1689); Injury (2348)
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 foot plate of the patient support for stitching fell on the foot of the doctor. Operator received skin abrasion. Minor injury occurred.
 
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Brand NameDIGITALDIAGNOST 3.1.X
Type of DeviceSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS DMC GMBH
roentgenstr. 24
hamburg 22335
GM 22335
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
dusty leppert
roentgenstr. 24
hamburg 22335
GM   22335
405078-229
MDR Report Key8496015
MDR Text Key141454358
Report Number3003768251-2019-00005
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K131483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number712026
Device Catalogue Number712026
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/12/2019
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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