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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST SINGLE DETECTOR; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Model Number 712020
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
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.No injury occurred.
 
Manufacturer Narrative
The digitaldiagnost 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.Correction: h6 result and conclusion g3: from foreign to health professional.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
DIGITALDIAGNOST SINGLE DETECTOR
Type of Device
SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS DMC GMBH
roentgenstr. 24
hamburg 22335
GM  22335
MDR Report Key9621209
MDR Text Key181522125
Report Number3003768251-2020-00001
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
PMA/PMN Number
K090625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number712020
Device Catalogue Number712020
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/09/2020
Initial Date FDA Received01/23/2020
Supplement Dates Manufacturer Received01/09/2020
Supplement Dates FDA Received09/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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