DR 600
Received Oct 18, 2019 · Event occurred Oct 17, 2019
Report 9613152-2019-00002 · MDR key 9207659
Device
Generic name
Dr 600
Manufacturer
Agfa-gevaert Healthcare GmbhProduct problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER IN THE (B)(6) REPORTED TO (B)(4) THE COLLIMATOR POSSIBLY FELL FROM THE DR 600 SYSTEM. THE CUSTOMER STATES THEY WERE NOT SURE EXACTLY WHAT HAS FALLEN OFF THE DR 600 SYSTEM BUT IT SOUNDS LIKE THE COLLIMATOR. INVESTIGATION IS UNDERWAY AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THESE EVENTS. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USERS FOR THIS EVENT.
Additional Manufacturer Narrative
THIS FINAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECT DETAILS OF THE INCIDENT, THE ROOT CAUSE, AND ACTIONS TAKEN. AGFA SERVICE RESPONDED AND CONFIRMED THE DETAILS OF THE INCIDENT WITH THE CUSTOMER. THE COLLIMATOR DID NOT FALL FROM THE AGFA DR 600 SYSTEM AS PREVIOUSLY REPORTED. THE COLLIMATOR FLANGE WAS SOMEWHAT LOOSE AND SHOWED SOME MECHANICAL PLAY. THE ROOT CAUSE IS CONFIRMED AS THE COLLIMATOR SYSTEM FLANGE BECAME LOOSENED. AGFA SERVICE REMOVED THE COLLIMATOR, ADJUSTED AND TIGHTENED THE FLANGE, AND REFIT THE THE COLLIMATOR TO THE DR 600 SYSTEM. THE SYSTEM WAS TESTED AND TEST EXPOSURES COMPLETED SUCCESSFULLY. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THESE EVENTS.
Description of Event or Problem
THIS SUPPLEMENT REPORT #1 IS BEING SUBMITTED TO PROVIDE CORRECT DETAILS OF THE INCIDENT,THE ROOT CAUSE, AND ACTIONS TAKEN.
Remedial action
- Repair