MAUDE Adverse Event Report: SOMNETICS TRANSCEND; NON-CONTINUOUS VENTILATOR

Model Number	506001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(4) 2024 patient reported through multiple channels that they had developed pneumonia from the use of our cpap device.An investigative call was placed by nathan waste on (b)(6) 2024 to gather additonal information from the patient on the use of the device and the details pertaining to their pneumonia.The patient reported using the device on a recent trip (dates were not disclosed) and that the device dried out their sinuses.The patient eventually developed pneumonia which they reported was due to the dried-out sinuses.The patient reported seeing a doctor and being prescribed antibiotics.Patient's complaint was that they were not informed about the potential for the cpap device to cause sinus dryness.Adverse effects of cpap usage are listed in the user guide (ifu 104143 rev f) that was included with the cpap (on page 4 and 5).The following listed adverse effects related to this complaint are as follows: - irritation/dryness of the mouth, nose, or throat.- ear or sinus discomfort.As this is a known adverse effect, there is an optional accessory (heat moisture exchanger) that the patient did not use which provides waterless humidification to assist with these types of symptoms.On (b)(6) 2024 as part of our investigation we reached out to the patient to follow up on their well being, and to request that the cpap be returned for evaluation.As of 10/24/24, the patient has not responded.
Event or Problem Description
Patient reported that the cpap unit dried out their sinuses resulting in an infection that lead to pneumonia.Patient reported they visited a doctor and that they were prescribed antibiotics for pneumonia.The patient did not report using the optional heat and moisture exchanger (waterless humidifcation) that is available for the device.

• Brand Name: TRANSCEND
• Common Device Name: NON-CONTINUOUS VENTILATOR
• Manufacturer (Section D): SOMNETICS; 103 osborne road ne; fridley MN 55432
• Manufacturer (Section G): AURORA TECHNOLOGY PTE LTD; 54 serangoon north avenue 4; level 4; 55585 4; SN 555854
• Manufacturer Contact: nathan waste ; 103 osborne road ne; fridley, MN 55432 ; 6516211801
• MDR Report Key: 22292942
• Report Number: 3008770104-2024-00001
• Device Sequence Number: 8263453
• Product Code: BZD
• UDI-Device Identifier: M9505060010
• UDI-Public: +M9505060010/16D20240601/
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: Lay User/Patient
• Device Model Number: 506001
• Device Catalogue Number: 506001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CPAP MASK
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 59 KG