Nellcor DSN560Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521582538), received between Jul 8, 2019 and Jun 30, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2022Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE PRODUCT GAVE INACCURATE EQUIPMENT TEST VALUES. THE BASELINE WAS NOT SET PRIOR TO THE START OF THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880953 ↗
• InjuryNov 1, 2019Battery Problem; Battery Problem

  ACCORDING TO THE REPORTER, DURING SERVICE AND REPAIR, THE DEVICE HAD A DEFECTIVE BATTERY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 9266218 ↗
• MalfunctionJul 8, 2019Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, THE UNIT HAD ALARM DEFECT. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8769181 ↗