NA MU-110ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04931921108437), received between Aug 16, 2023 and Dec 9, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (5 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.

• MalfunctionDec 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED THAT THEY ARE EXPERIENCING INCORRECT CPAP PRESSURE READINGS DURING STUDIES. FOR EXAMPLE, WHEN SETTING CPAP PRESSURE TO 12 CM H2O, THE STUDY DISPLAYS A VALUE OF 2.2. AFTER TROUBLESHOOTING WITH THE CUSTOMER, IT WAS DETERMINED THAT THE ISSUE WAS WITH THE MU-110AK. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887881 ↗
• MalfunctionDec 21, 2023Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT ON 11/06/2023 THEY HAD ANOTHER OCCURRENCE OF THE PULSE OXIMETER (SPO2 FINGER PROBE) LEAVING SKIN BLISTERS ON THE PATIENT FINGER. OTHER RELATED TICKETS: 300337771, 300337766, 300340025, 300340026 - DIFFERENT THIRD PARTY PROBE BEING USED.

  Patient problems: Blister; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378753 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THEY HAD 4 SEPARATE OCCURRENCES OF THE PULSE OXIMETER (SPO2 FINGER PROBE) LEAVING SKIN BLISTERS ON PATIENT FINGER. THIS IS FOR THE (B)(6) 2023 OCCURRENCE. THE ISSUE IS NOT FOR THE PSG-1100A SYSTEM ITSELF, AND IS FOR ACCESSORY SPO2 PROBE BEING USED WITH THE SYSTEM. OTHER RELATED COMPLAINTS WILL BE REPORTED: (B)(4) - DIFFERENT PROBE MODEL BEING USED; (B)(4) - DIFFERENT PROBE MODEL BEING USED; (B)(4) - DIFFERENT PROBE MODEL BEING USED.

  Patient problems: Blister; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561848 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THEY HAD 4 SEPARATE OCCURRENCES OF THE PULSE OXIMETER (SPO2 FINGER PROBE) LEAVING SKIN BLISTERS ON PATIENT FINGER. THIS IS FOR THE (B)(6) 2023 OCCURRENCE. THE ISSUE IS NOT FOR THE PSG-1100A SYSTEM ITSELF, AND IS FOR ACCESSORY SPO2 PROBE BEING USED WITH THE SYSTEM. OTHER RELATED COMPLAINTS WILL BE REPORTED: (B)(4) DIFFERENT PROBE MODEL BEING USED.

  Patient problems: Blister; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561736 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THEY HAD 4 SEPARATE OCCURRENCES OF THE PULSE OXIMETER (SPO2 FINGER PROBE) LEAVING SKIN BLISTERS ON PATIENT FINGER. THIS IS FOR THE (B)(6) 2023 OCCURRENCE; AND AS THEY DID NOT PROVIDE THE DAY IT OCCURRED, WE WILL NOTE IT AS (B)(6) 2023. THE ISSUE IS NOT FOR THE PSG-1100A SYSTEM ITSELF, AND IS FOR ACCESSORY SPO2 PROBE BEING USED WITH THE SYSTEM. OTHER RELATED COMPLAINTS WILL BE REPORTED: (B)(4) - DIFFERENT PROBE MODEL BEING USED.

  Patient problems: Blister; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561712 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THAT THEY HAD 4 SEPARATE OCCURRENCES OF THE PULSE OXIMETER (SPO2 FINGER PROBE) LEAVING SKIN BLISTERS ON PATIENT FINGER. THIS IS FOR THE (B)(6) 2023 OCCURRENCE. THE ISSUE IS NOT FOR THE PSG-1100A SYSTEM ITSELF, AND IS FOR ACCESSORY SPO2 PROBE BEING USED WITH THE SYSTEM. OTHER RELATED COMPLAINTS WILL BE REPORTED: (B)(4). DIFFERENT PROBE MODEL BEING USED.

  Patient problems: Blister; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561697 ↗