HORIZON
Received Sep 6, 2024 · Event occurred Aug 21, 2024
Report 1220984-2024-00102 · MDR key 20162571
Device
Generic name
Densitometer, Bone
Manufacturer
Hologic, IncModel number
HORIZON-CICatalog number
HORIZON-CI
Product problems
- Fire
- Sparking
- Fire
- Sparking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H3 OTHER TEXT : OTHER.
Description of Event or Problem
IT WAS REPORTED ON AUGUST 21, THAT AFTER TURNING ON THE HORIZON DEVICE, THE TECHNICIAN HEARD A LOUD POPPING SOUND, THEN SPARKS, THEN A FLAME AND SMOKE. NO ADDITIONAL INFORMATION AVAILABLE.
Additional Manufacturer Narrative
DEVICES EVALUATION BY FIELD ENGINEER: A FIELD ENGINEER EXAMINED THE DEVICE AND COULD NOT CONFIRM IF FLAMES WERE COMING OUT OF THE MACHINE AS THERE WAS NO DAMAGE TO SURROUNDING AREAS. THE FIELD ENGINEER THE LOW-VOLTAGE POWER SUPPLY WAS REPLACED AND THE SYSTEM WAS RETURNED TO SERVICE.