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 2019-01-25 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa N.v..

Event Text Entries

[136604745] Agfa healthcare nv has recently changed the company structure into two legal entities, named agfa healthcare and agfa nv. This report is for agfa n. V. Agfa n. V's owner operator number is (b)(4). Agfa n. V. Is currently awaiting the assignment of a fda registration number. This report has been submitted via the manufacturer registration number (b)(4) for agfa healthcare n. V.
Patient Sequence No: 1, Text Type: N, H10


[136604746] A customer in the us reported to agfa when using their dx-d 100 system the collimator fell from the system. The customer reported in preparation to image a patient after heart surgery, the collimator fell off and hit the patient in the abdomen. The patient, who was medicated from surgery, indicated they were not hurt. The unit has been removed from service. Investigation is underway and a supplemental report will be provided. There has been no reported actual harm to patient or user during these events.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616389-2019-00006
MDR Report Key8279115
Date Received2019-01-25
Date of Report2019-03-04
Date of Event2019-01-24
Date Mfgr Received2019-02-26
Device Manufacturer Date2012-02-01
Date Added to Maude2019-01-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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
Remedial ActionRP
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 Received2019-01-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2019-01-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.