inforMED
MalfunctionLSB

CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITY

Received Oct 23, 2019 · Event occurred Sep 30, 2019

Report 9616086-2019-00077 · MDR key 9226968

Device

Generic name

Unit, Fluidotherapy

Manufacturer

Djo, Llc

Model number

FLU115D

Product problems

  • Smoking
  • Smoking

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT THE MACHINE WAS FOUND TO BE SMOKING. THEY MOVED IT OUTSIDE AND COULD NOT GET THE CORN MEDIA TO STOP SMOLDERING SO THEY DUMPED WATER ON IT. THE MACHINE WAS FOUND PLUGGED INTO THE WALL BUT NOT TURNED ON. IT WAS REPORTED TO NOT HAVE BEEN USED THE PRIOR DAY. IT HAD ALLEGEDLY CREATED A LOT OF CORN DUST/PARTICULATE IN THE PREVIOUS MONTHS. THERE WAS NO PATIENT INVOLVEMENT / HARM. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.