NIM-Eclipse® NCCPU (UDI 00613994910677)Recalls & reported problems
Medtronic Xomed, Inc. · COMPUTER NCCPU NOTEBOOK · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994910677), received between Apr 16, 2019 and Apr 23, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Sense” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Failure to Sense1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2021Failure to Sense; Failure to Sense
ON FOLLOW-UP, IT WAS REPORTED THAT THE CUSTOMER STOPPED THE SURGERY BECAUSE THE MONITORING SHOWED SOME TOTALLY STRANGE VALUES COMPARED TO WHAT THEY HAVE MONITORED PREVIOUSLY (APPROX. 100 POINTS DIFFERENCE; FROM -240 TO -360 IN 40 MINUTES). THEY DID NOT MANAGE TO FIND A REASON FOR THIS UNEXPECTED CHANGE/DROP IN VALUES, AND FOR SAFETY REASONS THEY DECIDED TO STOP SURGERY. AT THE BEGINNING, THE DELAY WAS A FEW MINUTES, UNTIL THEY REPOSITIONED THE PATIENT; THEN THEY WAKED UP THE PATIENT TO CHECK FOR NEUROLOGICAL ISSUES, BUT EVERYTHING WAS OK; THEN THEY PUT THE PATIENT TO BACK TO SLEEP AND NOTICED THE SAME STRANGE VALUES. AT THIS POINT, FOR SAFETY REASONS THEY DECIDED TO STOP THE SURGERY. THE PATIENT WAS OK, WITHOUT ANY HARM SUFFERED; SURGERY WAS NOT PERFORMED ANYMORE. AFTER ONE WEEK PATIENT WAS RELEASED FROM THE HOSPITAL AND THEY AGREED TOGETHER THAT SHE WILL COME BACK FOR SURGERY IN AUTUMN TIME. FOR TROUBLESHOOTING, THERE WAS REPOSITIONING OF THE PATIENT (HEAD, NECK, RELAXED LEGS); WAKED PATIENT UP FROM ANESTHESIA AND CHECK FOR NEUROLOGICAL SIGNS/DAMAGE (NOTHING HAPPENED), THEY PUT THE PATIENT BACK TO SLEEP, RELAXED THE PATIENT AGAIN ¿ ALL THESE SHOULD BE VISIBLE ON THE TRACK RECORD:
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11715613 ↗MalfunctionApr 16, 2019Use of Device Problem; Use of Device Problem
THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8518223 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.