inforMED
MalfunctionJAF

NICOLET ELITE

Received Dec 23, 2019 · Event occurred Nov 27, 2019

Report 3010611950-2019-00077 · MDR key 9512785

Device

Generic name

Elite Auto Shut-off 200r Main

Model number

XMD008

Catalog number

XMD008

Lot number

ECQ0529

Product problems

  • Device Sensing Problem
  • Environmental Compatibility Problem
  • Device Sensing Problem
  • Environmental Compatibility Problem

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

REFERENCE (B)(4). DEVICE RETURNED TO NATUS ON DECEMBER 26, 2019. PER DEPOT REPAIR NOTES: "REPLACED THE SPEAKER, THE FRONT HOUSING AND THE PROBE CABLE. INSTALLED A NEW BATTERY AND TESTED, THE UNIT PASSED ALL FUNCTIONAL TESTS. THE PROBE WAS EVALUATED AND THERE WERE NO PROBELMS FOUND WITH THE PROBE."

Additional Manufacturer Narrative

REFERENCE (B)(4). CUSTOMER STATES THERE IS EXCESSIVE NOISE WHEN TRYING TO HEAR THE FETAL HEARTBEAT. CUSTOMER WAS PROVIDED A QUOTE FOR REPAIR ON THE UNIT ON (B)(6), 2019. ADDITIONAL ATTEMPT TO COLLECT PRODUCT MADE ON (B)(6), 2019 WHERE CUSTOMER CONFIRMED THEY WERE STILL IN POSSESSION AND PLANNED ON RETURNING UNIT. ADVERSE EVENT QUESTIONNAIRE SENT TO CUSTOMER FOR ADDITIONAL FOLLOW UP ON PATIENT INVOLVEMENT ON (B)(6) AND (B)(6), 2019.

Description of Event or Problem

NOISE PREVENTS USER FROM BEING ABLE TO HEAR FETAL HEARTBEAT.