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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 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
Int.Ref.10011642 the digitaldiagnost is a direct digital radiography system with flat detector technology based on modular components to allow for customization for all radiographic applications and workload requirements.The patient support for stitching is an accessory that allows the examination of full leg or full spine with the patient standing upright.For easy use, the patient support for stitching has wheels and a folding footboard.The footboard is connected to the frame via two hinges and a break cylinder and has to be folded up and fixed by a hook (plastic clip) 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 footplate from falling on the foot of a person.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.Philips field service engineer investigated at site.The hospital radiographer states that the issued happened when he let the foot board down, without stepping on it.However the capa investigation shows that a breaking of the fixation of the brake cylinder is not possible without additional external forces, therefore use error.Furthermore it was concluded that the risk is acceptable per risk benefit determination.Philips field service engineer replaced the complete patient support for stitching against a newer version.This issue is further monitored and trended.Correction: h6 result and conclusion 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 DUAL 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 Key9437548
MDR Text Key181521994
Report Number3003768251-2019-00020
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 11/19/2019
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 Number712022
Device Catalogue Number712022
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received12/09/2019
Supplement Dates Manufacturer Received11/19/2019
Supplement Dates FDA Received06/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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