MAUDE Adverse Event Report: MAXTEC LLC MAXO2ME; OXYGEN GAS ANALYZER

Model Number	R230P01
Medical Device Problem Codes	Calibration Problem (2890); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Assessment of risk: it was reported though the device malfunctioned while being used on a patient, there was no effect on the patient.The end user was contacted multiple times with no response and no further information could be procured.Maxtec requested the device for further investigation and the device was not returned.Since maxtec could not investigate the device involved, a risk assessment cannot be provided at this time.Efforts to communicate with the complainant/user will continue to facilitate a detailed investigation.Device detail: description: maxo2me p/n: r230p01 l/n: fl1429 dom: 19 nov, 2024 (b)(4).Complaint/maude database review: a review of maxtec's complaint files and the maude database did not result in a significant review since no mdr reports could be found for the device in question.Root cause: the most probable root cause is unknown at this time since maxtec was unable to investigate the device, or receive any additional information from the end user.Corrective actions: there is no corrective action identified as the root cause is unknown.Has context menu.
Event or Problem Description
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.
Additional Manufacturer Narrative
Investigation activities: issue: 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.Description: monitor, maxo2me, p/n: r230p01, l/n: fl14299, serial number: (b)(6), dom: on (b)(6) 2020.Our process requires each analyzer undergo 100% functional testing prior to release.Review of dhr records showed that the analyzer passed functional testing.A historical review of complaints was performed (nov 2020 - aug 2024).No additional complaints from this lot (maxo2me, lot number: fl14299) have been reported.Containment activities: a review of in-house inventory indicated that there was no additional product on hand of this assembly lot (job) number.A representative from the complainant (b)(6) heath) stated that the analyzer is not available for return.Corrections: since the sample was not returned, an evaluation could not be performed.Probable root cause: based on the information provided by the customer and the results of past service investigations this issue is most likely related to a calibration error.The e03, e05 and e07 error codes are for 'calibration' errors.E03: no valid calibration data available, make sure unit has reached thermal equilibrium and perform a calibration routine.E05: calibration error, sensor output higher than expected.E07: calibration error, sensor output is not stable.All error codes and the corresponding problem solving are described in the maxo2me user manual.Probable root causes include: the analyzer was calibrated in a gas other than 100% o2 or 20.9% o2 (can be resolved by re-calibrating).The maxo2me user manual states, "ensure the calibration gas is either room air or 100% oxygen".The analyzer was calibrated with an unstable gas flow, pressure or concentration (can be resolved by re-calibrating).The maxo2me user manual states, "ensure the calibration gas flow, pressure and concentration is constant.Allow sufficient time for the sensor to stabilize in the calibration gas and with room temperature".The unit's sensor was unstable.The unit's sensor cable has a short or is damaged.After review of our records and evaluation, the monitor was deemed to be fully functional when shipped.No issues were identified with the monitor in initial release testing.The unit was shipped from maxtec in nov 2020 and reported on jul 2024.Risk based on known functionality: the maxo2me oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults.It can be used in the pre-hospital, hospital, and sub-acute settings.The maxo2me is not intended as a life supporting device.Moderate risk, the issue resulted in a partial malfunction while in use.Per hazard analysis, maxo2me monitor (dcd-0059, rev 08): potential failure mode: the user does not understand the error code.Severity: 1 (negligible, results in no harm, delayed treatment [not resulting in harm], inconvenience, or temporary discomfort).Occurrence: 2 (remote, 1 in 10,000 to < 1 in 1,000) · risk: 2 (there are no individual risks identified where the overall risk score is >/= 5, but <12.This is primarily because this device does not control or deliver treatment or therapy and is only a monitoring device.The overall design of the maxo2me is substantially equivalent to products currently on the market with a history of safe and effective use and the benefits outweigh the risk).Corrective action: there are no additional corrective actions deemed necessary at this time.
Event or Problem Description
On june 6, 2024, maxtec llc received a notification from the fda of an mdr report filed by in june 2024, (b)(6).(b)(6) center.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: " 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.".

• Brand Name: MAXO2ME
• Common Device Name: OXYGEN GAS ANALYZER
• Manufacturer (Section D): MAXTEC LLC; 2305 s 1070 w; west valley city UT 84119
• Manufacturer (Section G): MAXTEC LLC; 2305 s 1070 w; west valley city UT 84119
• Manufacturer Contact: sri divya kadiyala ; 2305 s 1070 w; west valley city, UT 84119 ; 8007485355
• MDR Report Key: 22360246
• Report Number: 1000117260-2024-00002
• Device Sequence Number: 8586721
• Product Code: CCL
• UDI-Device Identifier: 00853061006951
• UDI-Public: 00853061006951
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: R230P01
• Device Catalogue Number: R230P01
• Device Lot Number: FL1429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown