DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-30 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa N.v..

Event Text Entries

[144965572] A customer in the us reported to agfa an event of unintended movement of their dx-d 100 system. The customer reported the dx-d 100 system continued to start and stop in different ways on its own and eventually hit a wall putting a hole into the wall. The unit was removed from service. Agfa onsite service investigation revealed there was a lack of subcontractor service maintenance and routine checking the cleanliness of the system, resulting in dust and debris accumulation on the system's chains, wheels, and inner dmc board which contributed to the unintended movement. The entire system was cleaned, including sprockets and chains. Maintenance checks were performed with corrections to switch settings, voltage adjustments, chain tensions, and dmc board and strain gauge replacements. The system was re-assembled and fully tested. The unit drove much smoother with no more noises from the drive system. The system now turns well with a stopping distance from full speed to about 2 feet. The system's reverse drive is straight and working correctly. The system was placed back into customer use with no further issues. There has been no reported harm to patient or user during these events.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3001556265-2019-00003
MDR Report Key8566115
Date Received2019-04-30
Date of Report2019-04-30
Date of Event2019-04-15
Date Mfgr Received2019-04-15
Date Added to Maude2019-04-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. CASSANDRA MCGOWAN
Manufacturer Street10 S ACADEMY STREET
Manufacturer CityGREENVILLE SC 29601
Manufacturer CountryUS
Manufacturer Postal29601
Manufacturer Phone8644211984
Manufacturer G1AGFA N.V.
Manufacturer StreetSEPTESTRAAT 27
Manufacturer CityMORTSEL, B2640
Manufacturer CountryBE
Manufacturer Postal CodeB2640
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100
Generic NameDX-D 100 MOBILE
Product CodeIZL
Date Received2019-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAGFA N.V.
Manufacturer AddressSEPTESTRAAT 27 MORTSEL, B2640 BE B2640


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-30

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