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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITAL DIAGNOSTIC SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Model Number 712032
Device Problems Device Stops Intermittently (1599); Computer Operating System Problem (2898); Electrical Shorting (2926)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Intermittent issues when booting system up, requiring multiple re-boots for system to eventually come up. This has been an issue for a while. Philips short handed and unable to address that week. Referred to unix to coordinate an on-site visit. Per site reporter- contacted unix to coordinate an on-site visit.
 
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Brand NameDIGITAL DIAGNOSTIC
Type of DeviceSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS DMC GMBH
janet book
1740 golden mile highway
monroeville PA 15146
MDR Report Key7104039
MDR Text Key94410816
Report Number7104039
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number712032
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2017
Event Location Hospital
Date Report to Manufacturer09/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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