Nellcor DS100A-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30884522042714), received between Apr 30, 2018 and Nov 11, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Readings” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K012891); they may or may not involve this specific model.

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.

• MalfunctionNov 11, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SENSOR WAS NOT READING CORRECTLY. IT WAS TESTED WITH A SENSOR SIMULATOR AND THE MONITOR WAS READING SPO2 CORRECTLY. THE SENSOR WAS REPLACED WITH A NEW ONE TO RESOLVE THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652566 ↗
• MalfunctionFeb 1, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD LOW READINGS. THE SENSOR WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18626739 ↗
• MalfunctionApr 19, 2021High Readings; High Readings

  ACCORDING TO THE REPORTER, THE MONITOR WAS NOT WORKING PROPERLY AND WOULD HAVE HIGH READINGS OF BP AND SPO2 HEART RATE OF 300. THE SENSOR WAS REPLACED AS A PRECAUTIONARY MEASURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688816 ↗
• MalfunctionMar 16, 2020Device Damaged Prior to Use; Low Readings; Device Damaged Prior to Use; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE PARAMETER WAS BROKEN, STATING THAT THE MONITOR WAS NOT PUMPING. IT WAS ALSO INDICATED THAT THE SENSOR WAS SHOWING SPO2 READING OF 94% WITH 100% OXYGEN. THE SENSOR WAS REPLACED. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835969 ↗
• MalfunctionMay 2, 2019High Readings; Low Readings; High Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT WAS GIVING HIGH PULSE RATE READINGS OF 200, HOWEVER WHEN THEY USED DIFFERENT DEVICE THE PATIENT'S PULSE RATE WAS 97. IT WAS ALSO REPORTED THE PRODUCT GAVE LOW SPO2 READINGS OF 50'S. NEVERTHELESS, WHEN TRIED WITH ANOTHER UNIT THE SPO2 RESULT WAS NORMAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573725 ↗
• MalfunctionApr 30, 2018High Readings; High Readings

  ACCORDING TO THE REPORTER, THE UNIT GAVE NORMAL PULSE RATE READING EXCEPT FOR ONE STUDENT WHICH GAVE A HIGH PULSE RATE READING OF 285. CUSTOMER INDICATED THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7472526 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012891. One submission often covers many models, so check the product and lot details in each record.

• Z-0664-05 · Oct 18, 2004 · Terminated
  Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.