MAUDE Adverse Event Report: RESPIRONICS, INC. COUGHASSIST T70; PERCUSSOR, POWERED-ELECTRIC

Model Number	1098160
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging dizziness and headache on a coughassist t70 device.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.No device has been returned.No further evaluation is possible at this time.Three attempts to have the device returned for evaluation and investigation were unsuccessful.If new information becomes available that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• Brand Name: COUGHASSIST T70
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 23023416
• Report Number: 2518422-2025-049178
• Device Sequence Number: 13065704
• Product Code: NHJ
• UDI-Device Identifier: 00606959005549
• UDI-Public: (01)00606959005549
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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: 1098160
• Device Catalogue Number: 1098160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2020
• 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 Sex: Unknown