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 2019-05-06 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa N.v..

Event Text Entries

[144965438] A customer in the us reported to agfa, the collimator fell from their dx-d 100 system. The customer reported when getting off the elevator the collimator assembly detached from the tube overhead of the dxd 100 system. Agfa service responded and first cleaned the area on the collimator where the tabs are located. The local agfa service engineer then drove the pins in and out to verify the function of the pins. All four pins worked and visually looked ok. The system collimator assembly was reset to the system. Agfa local service drove the unit and tested the collimator several times. With each test drive, the system tested ok. 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 Number3001556265-2019-00004
MDR Report Key8584108
Date Received2019-05-06
Date of Report2019-05-06
Date of Event2019-04-15
Date Mfgr Received2019-04-15
Device Manufacturer Date2013-06-01
Date Added to Maude2019-05-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Received2019-05-06
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 2019-05-06

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