MAUDE Adverse Event Report: MAXTEC MAXVENTURI; CONTINUOUS USE MONITOR OF OXYGEN CONCENTRATION

Model Number	R211P03-027
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the event was caused due to a pooling of water in the tube when used in a cpap environment.This pooling of water may result in an increase in backpressure and therefore a reduction of flow reaching the patient which may cause the feeling of "less powerful" treatment.The report stated that the maxventuri alarmed (exp heater wire).It should be noted that the maxventuri does not contain an alarm system or connection to the exp heater wire.We were unable to gain information clarifying what product in the user's setup alarmed.Maxtec's complaint database from march 2008 to february 2021 did not identify complaints related to observations described in the report.The maude database was reviewed from march 2008 to february 2021, product code ccl: there were a total of 34 reportable events; 0 out of the 34 events pertained to the maxventuri; 0 out of the 34 events pertained to similar observations provided in the (b)(6) report.No information reviewed during the historical data analysis suggested that the root cause was related to the maxtec maxventuri.The (b)(6) report stated that the facility took actions that included checking tubing regularly and draining excess fluid away when the patient was on cpap.The manufacture or the manufacturer's part number listed in the (b)(6) report is not indicated as an approved circuit for use with our device as outlined in the instructions for use (ifu), r211m03 rev t, provided with the maxventuri.The probable root cause of the incident was off-label use which resulted from a failure to follow maxtec's instructions for use.We are unable to determine the exact point of failure in the user's setup.As the ifu clearly states the approved disposable interfaces to be used with the maxventuri, no corrective action has been deemed necessary regarding the interfaces at this time.
Event or Problem Description
Facility stated the following: patient's maxivent alarmed (exp heater wire) no visible cause.Could visually see that water had pooled in the tube, drained 150ml back into humidication circuit.Patient stated it felt hot and less powerful.Near miss as patient could have been exposed to large volumes of water through nasal passage - tubing had been checked and drained throughout the shift and regular inspected for faults.This incident has occured on more than one occasion with multiple devices with varying volumes of fluid.

• Brand Name: MAXVENTURI
• Common Device Name: CONTINUOUS USE MONITOR OF OXYGEN CONCENTRATION
• Manufacturer (Section D): MAXTEC; 2305 south 1070 west; salt lake city UT 84119
• MDR Report Key: 11422511
• Report Number: 1000117260-2021-00001
• Device Sequence Number: 14372301
• Product Code: CCL
• UDI-Device Identifier: 00817770020448
• UDI-Public: 00817770020448
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: R211P03-027
• Device Catalogue Number: R211P03-027
• Device Lot Number: FJ63699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other