MAUDE Adverse Event Report: RESPIRONICS, INC. COUGHASSIST CA E70 INTERNATIONAL; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number	1098159
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	08/24/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a male patient, 52 years old with a diagnosis of als, died on (b)(6) 2025, in the hospital in (b)(6) there was no evidence of a malfunction of the ca e70 international device.There is no allegation that the device contributed to the death.The complaint review has determined that due to insufficient information this will be reported.Although there is not an allegation that the device caused or contributed to the mentioned "death".The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.If any additional information is received, a follow-up report will be filed.

• Brand Name: COUGHASSIST CA E70 INTERNATIONAL
• 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 ; +1(724)733-0200
• MDR Report Key: 23026983
• Report Number: 2518422-2025-109989
• Device Sequence Number: 13125428
• Product Code: NHJ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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
• Device Model Number: 1098159
• Device Catalogue Number: 1098159
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2019
• 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: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 52 YR
• Patient Sex: Male