inforMED
MalfunctionILZ

CHATTANOOGA SAUNDERS CERVICAL TRCTN DVCE

Received Dec 2, 2019 · Event occurred Nov 13, 2019

Report 9616086-2019-00084 · MDR key 9398732

Device

Generic name

Accessories, Traction

Manufacturer

Djo, Llc

Model number

199594

Product problems

  • Device Slipped
  • Device Slipped

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

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 "UNIT JUMPS/JERKS IN MOVEMENT WHEN PATIENT RELEASE AIR ALSO THE PUMP IS VERY HARD TO USE". [SIC] THERE WAS NO REPORTED PATIENT HARM.