MAUDE Adverse Event Report: RESMED LTD MOBI AMER1

Model Number	35001
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to resmed for an engineering investigation.Initial evaluation of the device could not confirm low pressure, although a low oxygen purity error message was confirmed.The investigation methods, results and conclusion are not finalized at this stage.When more information is available, a supplemental report will be submitted.Resmed reference#: (b)(4).Pending evaluation.
Event or Problem Description
It was reported to resmed that a patient using a mobile device felt tired, lightheaded and had an oxygen desaturation due to no air pressure coming out of the device.Patient was placed on an alternate oxygen source and o2 saturation increased to normal levels.
Additional Manufacturer Narrative
The mobi device was returned to resmed for an investigation.Performance testing could not reproduce the reported complaint and review of the device data logs could not confirm the reported complaint.Performance testing revealed that the device was not producing oxygen within specification.Visual inspection of the device revealed tobacco contamination.The investigation determined that the root cause was degraded material contributed by contamination.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that a patient using a mobi device felt tired, lightheaded and had an oxygen desaturation due to no air pressure coming out of the device.Patient was placed on an alternate oxygen source and o2 saturation increased to normal levels.

• Brand Name: MOBI AMER1
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 10533020
• Report Number: 3007573469-2020-00880
• Device Sequence Number: 3208474
• Product Code: CBK
• UDI-Device Identifier: 09353645350018
• UDI-Public: (01)09353645350018(11)200118(10)1431744
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020
• Report Date (Section F): 11/16/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 35001
• Device Catalogue Number: 35001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/23/2020
• Device Age: 6 MO
• Date Report to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 65
• Date Report Sent to FDA: 11/16/2020