MalfunctionIYB
DCTM
Received Oct 19, 2015 · Event occurred Oct 22, 2014
Report 1418964-2015-00002 · MDR key 5159403
Device
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE INITIALLY DID NOT SUBMIT A MEDICAL DEVICE REPORT FOR THIS EVENT SINCE WE ARE NOT THE MANUFACTURER/MARKETER AS REFERENCED IN 21 CFR 803.50(A). RECENTLY WE HAVE LEARNED THAT PER 21 CFR 803.22(B)(2) WE ARE REQUIRED TO FILE A REPORT AND THEREFORE WE ARE NOW SUBMITTING THIS REPORT.
Description of Event or Problem
THE X-RAY TUBE AND COLLIMATOR FROM A OVERHEAD TUBE CRANE SUDDENLY FELL. NO INJURIES WERE REPORTED.
Remedial action
- Replace