DUODIAGNOST
Received Aug 31, 2016 · Event occurred Aug 23, 2016
Report 3003768251-2016-00005 · MDR key 5917325
Device
Generic name
Interventional Fluoroscopic X-ray System
Manufacturer
Philips Medical Systems Dmc GmbhModel number
707015Catalog number
707015
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
(B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem
THE CUSTOMER HAS COMPLAINED THAT AN OPERATOR HAS BROKEN ONE TOE DURING PREPARING THE FOOTREST AT THE TABLE TOP FOR PATIENT POSITIONING.
Additional Manufacturer Narrative
THE DUODIAGNOST SYSTEM IS A REMOTE CONTROLLED X-RAY UNIT FOR CONVENTIONAL FLUOROSCOPY AND RADIOGRAPHY. THE PATIENT TABLE CAN BE CONTINUOUSLY TILTED. A DETACHABLE FOOTREST FOR THE PATIENT IS MANDATORY DURING TABLE TILTING. THE PHILIPS HEALTHCARE FIELD SERVICE ENGINEER HAS INVESTIGATED AT SITE AND CONFIRMED THE REPORTED ISSUE. HE FOUND BOTH WELDED HOOKS/TEETH, WHICH LOCK THE FOOTREST INTO THE TABLE TOP, WERE BROKEN OFF. ONE BROKEN HOOK WAS FOUND ON THE FLOOR. THE SECOND ONE WAS UNTRACEABLE. A SIMULATION DEMONSTRATED THAT IN CASE OF ONE BROKEN HOOK/TOOTH THE FUNCTION OF FOOTREST IS STILL GIVEN. ONLY AFTER FAILURE OF BOTH HOOK/TOOTH THE FUNCTION IS NO LONGER GIVEN. IN CASE OF A BROKEN HOOK/TOOTH THE FOOTREST STAYS FUNCTIONAL IN PLACE AS LONG AS THE FOOTREST IS NOT REMOVED FROM THE TABLE. IF THE FOOTREST WILL BE DETACHED FROM THE TABLE THE BROKEN HOOK/TOOTH MIGHT FALL APART. THE INSTRUCTION FOR USE CLEARLY WARN THE OPERATOR THAT UPON THE FOOTREST MOUNTING, THE CORRECT LOCKING MUST BE CHECKED, AND DESCRIBE HOW THIS IS TO BE DONE. BASED ON THAT, A MISSING LOCKING FUNCTION IS CLEARLY RECOGNIZABLE.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL ONGOING ON THIS EVENT.
Additional Manufacturer Narrative
(B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT.