Nellcor N65-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521096738), received between Apr 23, 2018 and Jul 3, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2020Image Display Error/Artifact; Temperature Problem; Image Display Error/Artifact; Temperature Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN ERROR CODE 279 AND A SMOKE WAS OBSERVED. ONE OF THE SPRING WAS LOOSEN AND SHORTED TO THE MAIN BOARD. THEY NEED TO MANUALLY TURN OFF THE DEVICE. NO FLAME BUT A LITTLE BIT OF SMOKE WAS CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10227695 ↗
• MalfunctionJun 5, 2020Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW READING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10123912 ↗
• MalfunctionMar 5, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD AN INACCURATE READING. THE CUSTOMER REPORTED THAT THE READING IS LOWER THAN NORMAL. IT WAS I NDICATED THAT THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8390975 ↗
• MalfunctionNov 30, 2018Display or Visual Feedback Problem; Poor Quality Image; Display or Visual Feedback Problem; Poor Quality Image

  ACCORDING TO THE REPORTER, THE DEVICE HAD A DEFECTIVE SCREEN DISPLAY AND INCOMPLETE NUMBERS. IT WAS REPORTED THAT NUMBER NINE WAS DISPLAYED AS FIVE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8119580 ↗
• MalfunctionOct 3, 2018Poor Quality Image; Poor Quality Image

  ACCORDING TO THE REPORTER, THE UNIT'S LIQUID CRYSTAL DISPLAY(LCD) DISPLAY WAS INCOMPLETE AND THERE WAS A MISSING SEGMENT. THE CUSTOMER REPORTED THAT IT PROVIDED READINGS IN ACTUAL MEASUREMENTS. THE LACKED DISPLAY WAS THE 10 DIGIT PART OF PULSE READING. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7929499 ↗
• MalfunctionApr 23, 2018Poor Quality Image; Poor Quality Image

  ACCORDING TO THE REPORTER, THE DEVICE HAD MISSING SEGMENTS AT THE CENTER OF THE READINGS. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7450917 ↗