MAXO2 ME R230P01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853061006951), received between Jun 30, 2025 and Jun 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Calibration 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Calibration Problem; Output Problem; Calibration Problem; Output Problem

  ON JUNE 6 2024, MAXTEC LLC RECEIVED A NOTIFICATION FROM THE FDA OF AN MDR REPORT FILED BY IN JUNE 2024, (B)(6). THE PROBLEM WAS NEVER REPORTED TO THE MANUFACTURER THOUGH THE MEDWATCH REPORT MENTIONS THE COMPLAINANT HAS REPORTED THE EVENT TO THE MANUFACTURER. THE DESCRIPTION IS BELOW VERBATIM - " DESCRIBE THE EVENT OR PROBLEM: O2 MONITOR/ANALYZER WAS NOT READING FIO2 CORRECTLY. ANALYZER REMOVED FROM JET VENTILATOR AND ATTEMPTED TO RE-CALIBRATE ANALYZER. MULTIPLE ERROR CODES WERE DISPLAYED E03, E05, E07. O2 CELL AND CABLE CONNECTIONS TIGHT. NO EFFECT ON PATIENT. NEW ANALYZER PLACED INTO SERVICE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : MONITOR OXYGEN LEVELS. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360246 ↗