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

Model Number	1098159
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	12/08/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information that a person died while using the cough assist e-70.The cough assist e-70 was used on the patient instead of a ventilator.This event is a legal matter and is under investigation by the police who was the initial reporter of this event the police will commission an external expert for an investigation and states that it is not possible to send the device back to the manufacturer for further investigation at this time.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device not returned to the manufacturer.

• Brand Name: COUGH ASSIST E70
• Common Device Name: MECHANICAL INSUFFLATION/EXSUFFLATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18361475
• Report Number: 2518422-2023-36730
• Device Sequence Number: 18085561
• Product Code: NHJ
• UDI-Device Identifier: 00606959005532
• UDI-Public: 00606959005532
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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: Other
• Device Model Number: 1098159
• Device Catalogue Number: 1098159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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