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

Model Number	1063552
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information alleging that while a customer was plugging in an alice 6 head box, they received a shock.There was no harm or injury reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported the manufacturer received information alleging that while a customer was plugging in an alice 6 head box, they received a shock.There was no harm or injury reported.The device was returned to a third-party service center for evaluation.During the device evaluation, the device main board was found to be damaged.Additionally, the device's front cover was found to be damaged.The main board was replaced, the top enclosure assembly was replaced and the device was cleaned.

• Brand Name: ALICE 6, LDXS HEADBOX
• 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: 19169162
• Report Number: 2518422-2024-21857
• Device Sequence Number: 7085722
• Product Code: OLV
• UDI-Device Identifier: 00606959004214
• UDI-Public: 00606959004214
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K040595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: 1063552
• Device Catalogue Number: 1063552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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: Female