MAUDE Adverse Event Report: RESMED LTD AIRSENSE 10 AUTOSET USA CO

Model Number 37207

Device Problem Material Disintegration (1177)

Patient Problem Respiratory Distress (2045)

Event Type  malfunction  

Manufacturer Narrative

The airsense 10 device was returned to resmed for an investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.(b)(4).

Event Description

It was reported to resmed that a patient had difficulty breathing and found green material inside the airsense 10 autoset device.The patient reportedly went to the pulmonologist where it was determined that the patient was breathing at 60%.The patient was given an inhalant which reportedly helped for a few days.

Manufacturer Narrative

The airsense 10 autoset device was returned to resmed for an investigation.Visual inspection confirmed the reported complaint and revealed the acoustic foam of the pneumatic block was discolored and physically degraded.Chemical analysis testing was completed by a third party and determined the reported sanitizing system cleaning agent caused degradation of the components.The investigation determined that the reported event was due to physical abuse.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that a patient had difficulty breathing and found green material inside the airsense 10 autoset device.The patient reportedly went to the pulmonologist where it was determined that the patient was breathing at 60%.The patient was given an inhalant which reportedly helped for a few days.

Event Description

It was reported to resmed that a patient had difficulty breathing and pain from broken ribs due to cardiopulmonary resuscitation from an unrelated event several months earlier.Patient reported while cleaning the device several days later, green, spongy material was found inside the airsense 10 autoset device and water chamber.Patient reportedly went to the pulmonologist where it was determined that the patient was breathing at 60%.Patient was given an inhalant which reportedly helped for a few days.Patient reported her symptoms resolved after sneezing several times.

Manufacturer Narrative

Based on information available to resmed, a clinical assessment determined that it may be possible that the acoustic foam has been damaged during cleaning, however, it is not likely that the green particulates found in the device had caused the adverse events reported but is most likely due to her existing injuries.The patient reported using a soclean home ozone cleaning device.Use of ozone is not recommended, and it is not listed in the cleaning methods in resmed¿s instructions for use for the subject device, which also cautioned against modification of resmed¿s device.The degradation of the acoustic foam in the device that is the subject of the inquiry was determined to be the result of repeated use of a third party soclean home ozone cleaning device.Home use of ozone to clean the device has always been inconsistent with the resmed device¿s instructions for use; resmed now expressly cautions against use of ozone devices and excludes from coverage of resmed¿s limited warranty any damage caused by use of ozone devices.Soclean device requires users to modify their sleep device (here, a resmed airsense 10) by installing a soclean provided replacement humidifier lid, which contains connection ports permitting the direct introduction of ozone into the body of the resmed sleep device, thus facilitating ozone exposure of internal components in both the dry and wet air path.Per air 10 user guide: do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps or scented oils to clean the device, the water tub or air tubing.These solutions may cause damage or affect the humidifier performance and reduce the life of the products.Exposure to smoke, including cigarette, cigar or pipe smoke, as well as ozone or other gases, may damage the device.Damage caused by any of the foregoing will not be covered by resmed¿s limited warranty.Resmed¿s limited warranty does not cover: any damage caused as a result of improper use, abuse, modification or alteration of the product; repairs carried out by any service organization that has not been expressly authorized by resmed to perform such repairs; any damage or contamination due to cigarette, pipe, cigar or other smoke and d) any damage caused by exposure to ozone, activated oxygen or other gases.Resmed reference #: (b)(4).

• Brand Name: AIRSENSE 10 AUTOSET USA CO
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: ariana beck ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 8135944
• MDR Text Key: 129579185
• Report Number: 3004604967-2018-01726
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1265673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37207
• Device Catalogue Number: 37207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/02/2022
• Device Age: 14 MO
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 02/20/2019; 05/02/2022
• Supplement Dates FDA Received: 03/19/2019; 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 73 KG