MAUDE Adverse Event Report: RESPIRONICS, INC. ALICE NIGHTONE; VENTILATORY EFFORT RECORDER

Model Number 1113277

Device Problems Device Issue (2379); Insufficient Information (3190)

Patient Problems Burn, Thermal (2530); Full thickness (Third Degree) Burn (2696)

Event Date 09/22/2016

Event Type  Injury  

Event Description

An end user alleged that she sustained a burn injury while using an alice nightone portable diagnostic device during an in-home sleep study.There was no indication the user required treatment or medical intervention for the reported injury.The manufacturer also received a voluntary medwatch (b)(4) that describes a "2x2 centimeter circular burn" that is "full thickness" on the right center of the patient's chest.To date, the end user has refused to return the device for evaluation.The manufacturer's investigation is on-going.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

The manufacturer has made numerous attempts to obtain additional information, and to have the device returned for evaluation.To date, no product has been returned, and no further information has been provided.The manufacturer is unable to confirm the user's allegation she sustained a "burn injury" while using this device.The alice nightone is a physiological data recorder intended to collect and record data from multiple physiological channels.It is intended for use by or on the order of a physician.The alice nightone is intended for use in a supervised (hospital) or unsupervised (home) environment.Two aa (1.5v) alkaline batteries, or two aa (1.2v) rechargeable batteries are used to power the device, and it is designed to conform to relevant iec and en standards.To date, there have been no similar events reported for this device to any regulatory authority.The manufacturer will continue to monitor complaints.Based on the available information, the manufacturer concludes no further action is necessary at this time.If additional information is received, or if on evaluation a malfunction is discovered that could cause or contribute to harm or injury, a supplemental report will be filed.

• Brand Name: ALICE NIGHTONE
• Type of Device: VENTILATORY EFFORT RECORDER
• 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: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 6047932
• MDR Text Key: 58317052
• Report Number: 2518422-2016-04083
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Device Unattended
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1113277
• Device Catalogue Number: 1113277
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 101