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

Model Number	1098159
Medical Device Problem Codes	No Display/Image (1183); Failure to Power Up (1476); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging when a patient was using a coughassist e70 device, it started to release smoke from the back, and the screen went black.The device no longer works.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The device has not yet been returned for the manufacturer for evaluation.Should any additional information be received, a follow-up report will be filled.
Additional Manufacturer Narrative
The manufacturer received information alleging when a patient was using a coughassist e70 device, it started to release smoke from the back, and the screen went black.The device no longer works.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The device has not yet been returned for the manufacturer for evaluation.Multiple good-faith efforts have been completed to obtain additional information on 12/26/2025, 02/18/2026, and 03/11/2026 without customer response.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow-up/supplemental report will be completed.

• 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 ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 23899070
• Report Number: 2518422-2025-113289
• Device Sequence Number: 5128427
• Product Code: NHJ
• UDI-Device Identifier: 00606959005532
• UDI-Public: (01)00606959005532
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 12/18/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2020
• 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 Age: 36 YR
• Patient Sex: Male