MAUDE Adverse Event Report: MAXTEC, LLC MAXVENTURI; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Model Number MAXVENTURI

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device detail: description: maxventuri, blender diss/pole teleflex.P/n: r211p03-036.L/n: ea38699.Serial number: (b)(4).Dom: 02/27/2019.(b)(4).Symptom described in the complaint: "stopped delivering oxygen".Additional information requested: the initial reporter was contacted on 05/07/21, to provide additional information and to request the return of the device for investigation.There was no response.A follow up request was sent on 05/17/21.There was no response.Maxtec's complaint database: to identify any internal trends relating to the symptom described in the report.Maxtec's complete complaint database was searched for maxventuri complaints.There were no trends identified.The total available complaints date range was from (b)(6) 2017 - (b)(6 2021.Keywords, such as, stop.Deliver, and stopped delivering oxygen were used to identify similar events.There is one (1) complaint, (b)(4), relating to the symptom described involving the maxventuri.(b)(4) was received on 07/27/17, and states "unit stopped working." the unit was not returned for investigation and the complaint was closed.(b)(4) does not indicate a trend for the symptom described as there has not been another related complaint received in over 3 years.Maude database: to identify any trends relating to the symptom reported to maxtec, the maude database was searched from (b)(6) 2017 - (b)(6) 2021.The search terms used were product code ccl and product class: analyzer, gas, oxygen, gaseous-phase.There are zero additional (0) reports relating to "stopped delivering oxygen." there was one (1) report relating to "stopped delivering oxygen." the report is the initial report submitted by the end-user.This report is a response to the mdr submitted by the initial reporter.A summary of the reports is listed below: there are nine (9) reports listed on the maude database from (b)(6) 2017 - (b)(6) 2021.7 of the 9 reports were not related to the maxventuri device.2 of the 9 reports involved a maxventuri.One (1) report was the initial report submitted by the end-user that was previously mentioned above.The other report was not related to the symptom described in the initial report.Root cause: the root cause is unknown.Additional information could not be obtained.Summary: there was one (1) complaint received in 2017 related to the symptom describe reported to maxtec.The complaint does not indicate a trend in similar reports.There were zero (0) additional reports added to the maude database relating to the stopping of oxygen delivery from a maxventuri or ccl (analyzer, gas, oxygen, gaseous-phase) device.Additional information could not be obtained.The investigation results determined is that cause could not be established due to the absence of the defective sample for evaluation, and no like complaints or reports.The root cause is unknown.There is no additional information currently available.

Event Description

Event title: - -confidential- -.Describe the event or problem,: patient was on a high-flow cannula at 100%; cannula stopped delivering oxygen; patient was placed on bipap and there was no known harm to the patient.What was the original intended procedure?: high flow oxygen.What problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: MAXVENTURI
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Manufacturer (Section D): MAXTEC, LLC; 2305 s 1070 w; salt lake city UT 84119
• MDR Report Key: 11864089
• MDR Text Key: 265379837
• Report Number: 1000117260-2021-00005
• Device Sequence Number: 1
• Product Code: CCL
• UDI-Device Identifier: 00853061006296
• UDI-Public: 0100853061006296
• Combination Product (y/n): N
• PMA/PMN Number: K063488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAXVENTURI
• Device Catalogue Number: R211P03-036
• Device Lot Number: EA38699
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR