MasimoSET uSpO2 Masimo SET Oximetry Cable, USB signal extraction pulse oximeter 3412Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843997007252), received between Aug 4, 2017 and Aug 4, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED OBSERVED DISCREPANCIES UP TO 12 POINTS (LESS) THAN THE SATURATION (MASIMO) DETECTED BY PHILIPS MONITORS. (SAME SETTINGS). THEY HAVE ALSO TRIED TO SWAP THE APPLICATION SITES (INVERTING PHILIPS MONITOR WITH FABIAN HFOI VENTILATOR) BUT THE PROBLEM PERSISTS. SINCE ON FABIAN HFOI VENTILATOR THE MONITORING OF THE PATIENT'S FIO2 (WITH PRICO'S CONTROL IS AUTOMATIC) IS BOUND TO THE MASIMO MONITORING, WE WOULD NEED TO UNDERSTAND EXACTLY THE CAUSE OF THIS DISCREPANCY IN ORDER TO PREVENT SITUATIONS WHERE PATIENT IS AT RISK, AND IN CASE THERE WAS A RECALL (AS YOU HAD ANTICIPATED BY PHONE) I WOULD NEED TO HAVE MORE DETAILS IN ORDER TO BE ABLE TO COMMUNICATE TO ACUTRONIC AND PREVENT FURTHER DELIVERIES OF FAULTY MASIMO CABLES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6769555 ↗
• MalfunctionAug 4, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED OBSERVED DISCREPANCIES UP TO 12 POINTS (LESS) THAN THE SATURATION (MASIMO) DETECTED BY PHILIPS MONITORS. (SAME SETTINGS). THEY HAVE ALSO TRIED TO SWAP THE APPLICATION SITES (INVERTING PHILIPS MONITOR WITH FABIAN HFOI VENTILATOR) BUT THE PROBLEM PERSISTS. SINCE ON FABIAN HFOI VENTILATOR THE MONITORING OF THE PATIENT'S FIO2 (WITH PRICO'S CONTROL IS AUTOMATIC) IS BOUND TO THE MASIMO MONITORING, WE WOULD NEED TO UNDERSTAND EXACTLY THE CAUSE OF THIS DISCREPANCY IN ORDER TO PREVENT SITUATIONS WHERE PATIENT IS AT RISK, AND IN CASE THERE WAS A RECALL (AS YOU HAD ANTICIPATED BY PHONE) I WOULD NEED TO HAVE MORE DETAILS IN ORDER TO BE ABLE TO COMMUNICATE TO ACUTRONIC AND PREVENT FURTHER DELIVERIES OF FAULTY MASIMO CABLES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6769552 ↗
• MalfunctionAug 4, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED OBSERVED DISCREPANCIES UP TO 12 POINTS (LESS) THAN THE SATURATION (MASIMO) DETECTED BY PHILIPS MONITORS. (SAME SETTINGS). THEY HAVE ALSO TRIED TO SWAP THE APPLICATION SITES (INVERTING PHILIPS MONITOR WITH FABIAN HFOI VENTILATOR) BUT THE PROBLEM PERSISTS. SINCE ON FABIAN HFOI VENTILATOR THE MONITORING OF THE PATIENT'S FIO2 (WITH PRICO'S CONTROL IS AUTOMATIC) IS BOUND TO THE MASIMO MONITORING, WE WOULD NEED TO UNDERSTAND EXACTLY THE CAUSE OF THIS DISCREPANCY IN ORDER TO PREVENT SITUATIONS WHERE PATIENT IS AT RISK, AND IN CASE THERE WAS A RECALL (AS YOU HAD ANTICIPATED BY PHONE) I WOULD NEED TO HAVE MORE DETAILS IN ORDER TO BE ABLE TO COMMUNICATE TO ACUTRONIC AND PREVENT FURTHER DELIVERIES OF FAULTY MASIMO CABLES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6769551 ↗
• MalfunctionAug 4, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED OBSERVED DISCREPANCIES UP TO 12 POINTS (LESS) THAN THE SATURATION (MASIMO) DETECTED BY (B)(4). (SAME SETTINGS). THEY HAVE ALSO TRIED TO SWAP THE APPLICATION SITES (INVERTING PHILIPS MONITOR WITH FABIAN HFOI VENTILATOR) BUT THE PROBLEM PERSISTS. SINCE ON FABIAN HFOI VENTILATOR THE MONITORING OF THE PATIENT'S FIO2 (WITH PRICO'S CONTROL IS AUTOMATIC) IS BOUND TO THE MASIMO MONITORING, WE WOULD NEED TO UNDERSTAND EXACTLY THE CAUSE OF THIS DISCREPANCY IN ORDER TO PREVENT SITUATIONS WHERE PATIENT IS AT RISK, AND IN CASE THERE WAS A RECALL (AS YOU HAD ANTICIPATED BY PHONE) I WOULD NEED TO HAVE MORE DETAILS IN ORDER TO BE ABLE TO COMMUNICATE TO ACUTRONIC AND PREVENT FURTHER DELIVERIES OF FAULTY MASIMO CABLES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6769548 ↗