inforMED
MalfunctionDSB

*

Received Dec 27, 2005

Report MW1037476 · MDR key 661565

Device

Generic name

Zoe-bio Impedance Monitor

Model number

*

Catalog number

*

Lot number

PN 41610/H1117/G1239

Product problems

  • Unable to Obtain Readings
  • Repair
  • Cable, defective

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THIS DEVICE IS USED TO MONITOR FLUID ACCUMULATION IN THE CHEST OF CHF PTS WHO HAVE BEEN IN AND OUT OF THE HOSP ON TWO OR MORE OCCASIONS IN THE LAST SIX MONTHS. A PILOT STUDY WAS DONE AND IT WAS FOUND THAT THE CABLES HAD PROBLEMS. THERE WERE NO READINGS ON THE MACHINE. THREE CABLES WERE REPLACED ON TWO OCCASIONS BUT THERE WERE NO READINGS ON THE MONITOR.