MalfunctionKGI
HORIZON
Received Dec 14, 2017 · Event occurred Nov 15, 2017
Report 1220984-2017-00261 · MDR key 7119216
Device
Generic name
Densitometer, Bone
Manufacturer
Hologic, Inc.Model number
HORIZON-CICatalog number
N/A
Lot number
N/A
Product problems
- Device Stops Intermittently
- Device Displays Incorrect Message
- Device Stops Intermittently
- Device Displays Incorrect Message
Patient
Not reported
- Not Applicable
- Not Applicable
Narrative
Description of Event or Problem
IT WAS REPORTED THE SYSTEM STOPPED DURING A SCAN WITH FILTER DRUM ERRORS AND NOISE, CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THE FILTER DRUM NEEDED TO BE REPLACED. ONCE THIS WAS DONE, THE SYSTEM IS WORKING AS INTENDED.