MAUDE Adverse Event Report: RESPIRONICS, INC. COUGHASSIST; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number	1098159
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to a thermal complaint on a cough assist device.The manufacturer received information alleging whirring noise and burning smell coming from the device.There is no allegation of serious or permanent harm or injury.Medical intervention was not specified by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer was previously contacted in reference to a thermal complaint on a cough assist device.The manufacturer received information alleging whirring noise and burning smell coming from the device.There is no allegation of serious or permanent harm or injury.Medical intervention was not specified by the patient.Due to no customer information, good faith effort was unable to be done.Attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: COUGHASSIST
• Common Device Name: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 21724628
• Report Number: 2518422-2025-103527
• Device Sequence Number: 21016402
• Product Code: NHJ
• UDI-Device Identifier: 00606959005532
• UDI-Public: (01)00606959005532
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1098159
• Device Catalogue Number: 1098159
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown