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

Model Number 1098159

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 12/08/2023

Event Type  Death  

Event 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.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

• Brand Name: COUGH ASSIST E70
• Type of Device: 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
• MDR Text Key: 330930682
• Report Number: 2518422-2023-36730
• Device Sequence Number: 1
• Product Code: NHJ
• UDI-Device Identifier: 00606959005532
• UDI-Public: 00606959005532
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1098159
• Device Catalogue Number: 1098159
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death