inforMED

LIFETRACE

Received Sep 10, 2007 · Event occurred Sep 6, 2007

Report 925767 · MDR key 925767

Device

Generic name

Paper, Recording

Manufacturer

Kendall- Ltp

Model number

30597226

Catalog number

CMS4305

Lot number

*

Product problems

  • Design/structure problem
  • No Device Output
  • Tears, rips, holes in device, device material
  • Fitting Problem

Patient

*

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

Narrative

Description of Event or Problem

WE HAVE RECENTLY EXPERIENCED PROBLEMS WITH A VARIETY OF THE GE MEDICAL COROMETRICS FETAL MONITORS WHERE THE RECORDERS HAVE STOPPED PRINTING OR THE PAPER HAS TORN. IT WAS NOTICED THAT SOME OF THE PAPER USED IN THE FETAL MONITORS WAS SLIGHTLY WIDER THAN NORMAL AND CONTRIBUTED TO THE RECORDER FAILURE. BOTH SAMPLES OF THIS PAPER ARE PURCHASED FROM THE SAME AFTER MARKET MANUFACTURER. THE VENDOR WAS CONTACTED AND REQUESTS SAMPLES FOR ANALYSIS. THERE IS ONLY A SLIGHT DIFFERENCE BETWEEN THE TWO PAPER SIZES, ABOUT 3/32 INCHES OR 2.3 MM, SO IT IS DIFFICULT TO TELL THE TWO SIZES APART. THE PAPER SLIPS INTO THE RECORDER EASILY IF IT IS THE RIGHT SIZE. HOWEVER, WITH THE INCORRECT SIZE, IT IS PRETTY SNUG AND DIFFICULT TO REMOVE. USE OF THE WIDER PAPER CAUSES THE PAPER TO STOP PRINTING AND THERE HAVE BEEN COMPLAINTS THAT THE PAPER TEARS. TO ADDRESS THIS ISSUE INTERNALLY, THE PACKS THAT ARE WIDER THAN NORMAL HAVE BEEN COLLECTED.