MAUDE Adverse Event Report: MAXTEC, LLC MAXVENTURI; AIR/OXYGEN MIXER

Model Number R211P03-002

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/29/2022

Event Type  Death  

Manufacturer Narrative

Summary: the suspect unit was returned to maxtec on november 7, 2022.On november 17, 2022, the unit was tested by maxtec's service and repair technician.Functional testing was performed according to wi-4037 rev m maxventuri testing procedure.The unit passed all functional testing.It was noted that the oxygen sensor installed in the device was not a sensor manufactured by maxtec, llc nor was it the sensor identified for use in the maxventuri instructions for use.To attempt to recreate the drift stated by the patient's family, maxtec's service and repair technician ran the device for a continuous period.There was no drift identified.Maxtec, llc could not replicate the issue.A review of complaints, public databases, and sales was conducted to identify any trends relating to the issue described by the patient's family.There were no trends identified.Maxtec was unable to determine the root cause of the event described, however based on the investigation and the analysis of the returned unit there was no indication that the unit was malfunctioning or defective.Assessment of risk: the maxventuri is intended for use in high-flow oxygen therapy applications where the ability to deliver diluted oxygen is required.Oxygen being delivered from this device is for adult patients.The device is intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings.It is not intended as a life supporting device.An interruption in oxygen supply is a recognized and mitigated risk identified by maxtec per dcd- 0042 rev 09 hazard analysis, maxventuri family.The risk is mitigated by warning users in the instructions for use r211m03 rev u that the device does not contain alarms for interruption in gas supply to the device and that the device does not have alarms for oxygen level high or low alarms.The post market surveillance report for the maxventuri issued in november 2022 was reviewed, there was no change to the risk benefit assessment.Evaluation of returned product: the unit was returned and evaluated by maxtec's service and repair technician.It was noted that the unit was returned with a non-maxtec sensor.There was no testing or evaluation performed on the sensor.Functional testing was performed on the maxventuri according to wi-4037 rev m maxventuri testing procedure.The unit passed all functional testing.The reporter stated that the device did not pass the oxygen flow diagnostic test.Maxtec's service and repair technician conducted testing for the oxygen flow diagnostic test according to the specifications outlined in the service manual that was released at the time of the unit's date of manufacture, cdn4037k rev f.The unit passed the oxygen diagnostic test according to cdn4037k rev f.The acceptance criteria in cdn4037f rev f is slightly different than the current revision r211m01 rev h.The current revision requirement is a tighter acceptance criterion than the one listed in cdn4037k rev f.Further, if the device fails the oxygen diagnostic test the unit should be sent back to maxtec, llc for troubleshooting.As such, there is no patient risk impact due to the different criteria.Attempt to replicate the failure: the unit was set up according to wi-4037 rev m and ran for a period of 15 minutes.The oxygen concentration was measured at set intervals.After 15 minutes, there was no drift identified.Root cause: maxtec was unable to determine the root cause of the event described, however based on the investigation and the analysis of the returned unit there was no indication that the unit was malfunctioning or defective.Corrective actions: no corrective actions are deemed appropriate at this time.

Event Description

The customer reported that this device's oxygen delivery "drifted"- the patient's family believes this is the case.The rt/hospital facility has not determined this.The rt set the device to 100% at 7am.It was checked and confirmed to be at 100%.At 11am, the flow drifted down to 87%.The rt adjusted the device back to 100% and then the patient's oxygen saturation went up 90%.Around 12pm, the patient passed.The biomed has now done the flow diagnostic test and the device has passed but it failed the oxygen flow diagnostic test- the biomed is wondering if he needs to proceed since it passed that section.".

• Brand Name: MAXVENTURI
• Type of Device: AIR/OXYGEN MIXER
• Manufacturer (Section D): MAXTEC, LLC; 2305 s 1070 w; salt lake city UT 84119
• Manufacturer (Section G): MAXTEC, LLC; 2305 s 1070 w; salt lake city UT 84119
• Manufacturer Contact: christina sanchez ; 2305 s 1070 w; salt lake city, UT 84119 ; 3855498000
• MDR Report Key: 16122295
• MDR Text Key: 306918551
• Report Number: 1000117260-2023-00001
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K063488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: R211P03-002
• Device Lot Number: YK85199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death