MAUDE Adverse Event Report: RESPIRONICS, INC. COUGH ASSIST E70; MECHANICAL INSUFFLATION/EXSUFFLATOR

Model Number	1098159
Medical Device Problem Codes	No Display/Image (1183); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a ca e70 "display was not working".The device was sent to a third-party service center for evaluation.The customer complaint was not reproduced.The device to be sent back without evaluation based on the customer's decision as the end customer died in the meantime.A clinical assessment determined based on available information at this time, the alleged harm death is assessed as not related to the device in this case.Therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.A good faith effort attempt will be made to determine the cause of death.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging a ca e70 "display was not working".The device was sent to a third-party service center for evaluation.The customer complaint was not reproduced.The device to be sent back without evaluation based on the customer's decision as the end customer died in the meantime.A clinical assessment determined based on available information at this time, the alleged harm death is assessed as not related to the device in this case.Therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.A good faith effort attempt will be made to determine the cause of death.A follow-up report will be submitted when the manufacturer's investigation is complete.Previous follow up: multiple good faith efforts have been made to obtain additional information, without customer response.A final report is being submitted.If new information becomes available a follow up/supplemental report will be completed.New information/correction: additional good faith effort attempt will be made to determine the cause of death.If new information becomes available a follow up/supplemental report will be completed.A final report is not being submitted at this time.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging a ca e70 "display was not working".The device was sent to a third-party service center for evaluation.The customer complaint was not reproduced.The device to be sent back without evaluation based on the customer's decision as the end customer died in the meantime.A clinical assessment determined based on available information at this time, the alleged harm death is assessed as not related to the device in this case.Therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.A good faith effort attempt will be made to determine the cause of death.A follow-up report will be submitted when the manufacturer's investigation is complete.New information: multiple good faith efforts have been made to obtain additional information, without customer response.A final report is being submitted.If new information becomes available a follow up/supplemental report will be completed.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging a ca e70 "display was not working".The device was sent to a third-party service center for evaluation.The customer complaint was not reproduced.The device to be sent back without evaluation based on the customer's decision as the end customer died in the meantime.A clinical assessment determined based on available information at this time, the alleged harm death is assessed as not related to the device in this case.Therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.Additional good faith effort attempt will be made to determine the cause of death.If new information becomes available a follow up/supplemental report will be completed.A final report is not being submitted at this time.New information/correction: additional good faith effort attempt were made to the customer on (b)(6) 2025, (b)(6) 2025 and (b)(6) 2025 to determine the cause of death and were unsuccessful.A final report is not being submitted at this time.

• Brand Name: COUGH ASSIST E70
• Common Device Name: MECHANICAL INSUFFLATION/EXSUFFLATOR
• 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: 22577345
• Report Number: 2518422-2025-108150
• Device Sequence Number: 9784729
• Product Code: BYI
• UDI-Device Identifier: 00606959005532
• UDI-Public: (01)00606959005532
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/19/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 10/16/2025; Not provided; 10/24/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 10/16/2025; 10/20/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown