MAUDE Adverse Event Report: RESPIRONICS, INC. ALICE 6; STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH

Model Number	1063314
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from customer in reference to a alice 6, base station system, no allegation reported by the patient.There was no report of serious injury or harm.There is no medical intervention was specified.The device was returned to the third-party service center.During evaluation it was observed the sbc with electrical damage and additional failures observed hard disk front, right left cover with physical damage.There was one error has been identified and unit got scrapped.

• Brand Name: ALICE 6
• Common Device Name: STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH
• 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: 23413597
• Report Number: 2518422-2025-050122
• Device Sequence Number: 12998181
• Product Code: OLV
• UDI-Device Identifier: 00606959004207
• UDI-Public: (01)00606959004207
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: 1063314
• Device Catalogue Number: 1063314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2014
• 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