FDA Adverse Event Malfunction Summary report: N

DX-D600 - DXD IMAGING PACKAGE

MDR report key: 8245542 · Received January 14, 2019

Report

Report Number: 9616389-2019-00004
Event Type: Malfunction
Date Received: January 14, 2019
Date of Event: December 20, 2018
Report Date: January 14, 2019
Manufacturer: AGFA N.V.
Product Code: KPR
PMA / PMN Number: K112670
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 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 HEALTCARE N.V.

Description of Event or Problem · 1

A CUSTOMER IN (B)(6) REPORTED TO AGFA, WHILE USING THE DX-D 600 SYSTEM, THEY EXPERIENCED FAST DOWNWARD MOVEMENT OF THE TUBE. THE CUSTOMER REPORTED WHEN THE OMNI-BUTTON WAS PRESSED, THE DX-D 600 SYSTEM TUBE MOVED DOWNWARD IN A FAST MOTION. WHEN THE OMNI-BUTTON WAS RELEASED, THIS IMMEDIATELY STOPPED THE DOWNWARD FAST MOTION. AGFA SERVICE RESPONDED AND CHECKED THE SYSTEM. AGFA SERVICE TESTED THE GAS SPRINGS AND THE TENSION WAS OK. THE BALANCING WAS READJUSTED IN THE GAUGE BOARD AND THE COMPENSATION WAS ADJUSTED. THE SYSTEM WAS CALIBRATED AND TESTED OK. THE ROOT CAUSE IS DETERMINED TO BE DRIFTING OF THE GAUGE BOARD BALANCING CALIBRATION. THE UNIT IS NOW WORKING AS INTENDED AND NO FURTHER INCIDENTS HAVE BEEN REPORTED. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THESE EVENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
39009	DX-D600 - DXD IMAGING PACKAGE	DX-D 600 SYSTEM	KPR	AGFA N.V.

Patients

Seq	Age	Sex	Outcome	Treatment
1