FDA.reportPublic FDA data

MAUDE MDR 8231255

MDR report key
8231255
Report number
9616389-2019-00003
Event key
0
Event type
3
Date of event
2018-12-30
Date received
2019-01-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. CASSANDRA MCGOWAN
Address
10 S ACADEMY STREET GREENVILLE SC 29601 US
Phone
864-864-8644
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100DX-D 100 MOBILEAGFA N.V.IZLY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-090

Event Narratives#

N

Patient 1

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.

D

Patient 1

ON (B)(6) 2018, A CUSTOMER IN THE US REPORTED TO AGFA THAT WHEN USING THEIR DX-D 100 SYSTEM, THEY EXPERIENCED UNINTENDED MOVEMENT. THERE WERE THREE (3) EVENTS OF UNINTENDED MOVEMENT. AGFA IS REPORTING EACH EVENT. THIS MDR REPORT IS FOR THE THIRD EVENT. DURING THE FIRST EVENT, A TECH ATTEMPTED TO COMPLETE A PORTABLE EXAM, BUT WHEN THE TECH STARTED TO MOVE THE DX-D 100, THE SYSTEM TOOK OFF AND CRASHED INTO A CHAIR, BREAKING THE CHAIR. THE TECH ENGAGED THE EMERGENCY STOP AND ASKED ANOTHER TECH TO LOOK AT THE SYSTEM. THE FIRST EVENT HAS BEEN REPORTED TO FDA VIA AGFA REFERENCE NUMBER 9616389-2019-00001. DURING THE SECOND EVENT, THE SECOND TECH TRIED TO MOVE THE DX-D 100 SYSTEM, BUT THE SYSTEM ONCE AGAIN TOOK OFF AND CRASHED INTO SOME WHEELCHAIRS. THE TECH ENGAGED THE EMERGENCY STOP AND SHUT THE SYSTEM DOWN. THE SECOND EVENT HAS BEEN REPORTED TO FDA VIA AGFA REFERENCE NUMBER 9616389-2019-00002. DURING THE THIRD EVENT, THE SECOND TECH REBOOTED THE DX-D 100 SYSTEM, AND TRIED TO MOVE THE DX-D 100 AGAIN. THE SYSTEM AGAIN TOOK OFF AND RAN INTO A WALL. THE TECH ENGAGED THE EMERGENCY STOP AND DID NOT MOVE THE SYSTEM AGAIN. INVESTIGATION IS UNDERWAY AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THESE EVENTS.