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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
Int. Ref: (b)(4). The digital diagnostic system supports general radiographic imaging. For anatomies that are larger than the detector size, it is possible to make a series of exposures, covering the whole anatomy (for example full spine or full legs). These individual images can be "stitched" together via the software program. For proper patient positioning and support, the patient can be placed on the so called "patient support for stitching". For the ease of use, during transportation, the patient support for stitching has wheels and a folding footboard. The footboard is connected to the frame via two hinges and a brake cylinder. It has to be folded up and fixed by a hook for transportation, e. G. From one room to another. The brake cylinder has the task to ensure that the footboard lowers itself slowly (within 5-7 seconds) when the hook is released, to prevent the footboard from falling. If the operator steps on the footboard while it is still moving down, the mounting of the brake cylinder can break and the footboard fell down immediately. In a worst case, it may hit the foot of a person and break a bone. The circumstances why the mounting of break cylinder broke out of the frame of the patient support for stitching could not be clarified, but the capa and fco investigation concluded that breaking of the cylinder can only result from abnormal use, so if the stand is used as intended there is no risk. The patient support has been replaced. A capa investigation was conducted with the result of acceptable risk per risk benefit determination. This issue is further monitored and trended.
 
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. There was no person injured.
 
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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
MDR Report Key10725644
MDR Text Key212721024
Report Number3003768251-2020-01001
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeCH
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
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2020
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? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/23/2020
Event Location No Information
Date Manufacturer Received09/23/2020
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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