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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Model Number 712050
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Int. Ref. (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 one hinge of the foot board of the patient support for stitching was broken. This can lead to falling foot board and in worse case to a broken toe.
 
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Brand NameDIGITALDIAGNOST
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 Key10060928
MDR Text Key191403698
Report Number3003768251-2020-00003
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K982795
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number712050
Device Catalogue Number712050
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 Received04/30/2020
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
Removal/Correction NumberZ 2863 2018

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