MAUDE Adverse Event Report: RESPIRONICS,INC ALICE 6 LDX; AUTOMATIC EVENT DETECTION SOFTWARE FOR POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH

Model Number RJP1063315

Device Problem Insufficient Information (3190)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/15/2022

Event Type  malfunction  

Event Description

The manufacturer became aware of a complaint while using an alice 6 psg system.After the overnight study was performed, the user complained of alleged red marks/ burn marks on the forehead (from an eeg gold cup electrode) and on the arm from a masimo spo2 sensor which was very worn.The forehead redness was found to be from scratching the area after the sensor was removed, but the dermatologist felt the arm burn was more severe than a blister and prescribed ointment for that area.There was no serious patient harm or injury reported.The device with accessories has not yet been returned for investigation.The investigation is on-going.A follow up final report will be submitted when the investigation is complete.

Manufacturer Narrative

The manufacturer previously became aware of a complaint while using an alice 6 psg system.After the overnight study was performed, the user complained of an alleged red mark/ burn marks on the forehead (from an eeg gold cup electrode) and on the arm from a masimo spo2 sensor which was very worn.The forehead redness was found to be from scratching the area after the sensor was removed, but the dermatologist felt the arm burn was more severe than a blister and prescribed ointment for that area.There was no serious patient harm or injury reported.The device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Section(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation, investigation findings and investigation conclusions has been updated.Section d9 corrected in this report.

• Brand Name: ALICE 6 LDX
• Type of Device: AUTOMATIC EVENT DETECTION SOFTWARE FOR 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15670946
• MDR Text Key: 302394752
• Report Number: 2518422-2022-88077
• Device Sequence Number: 1
• Product Code: OLZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: RJP1063315
• Device Catalogue Number: RJP1063315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 11/27/2022
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ALICE 6 SPO2 MASIMO PATIENT CABLE (HP/LPM) 1075383.
• Patient Outcome(s): Other