MAUDE Adverse Event Report: NIGHTWARE INC. NIGHTWARE; DIGITAL THERAPY DEVICE TO REDUCE SLEEP DISTURBANCE FOR PSYCHIATRIC CONDITIONS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Event Description

Product: nightware https://nightware.Com/ medical finding: elevation in blood pressure; use of nightware increases blood pressure; manufacturer does not disclose this on their website or to physicians.However, on my review, this finding was reported to the fda for initial clearance.Nightware markets itself as having efficacy - efficacy results https://nightware.Com/professionals/ the following is from the manufacturers website accessed (b)(6) 2023 "given that this measure specifically indexes sleep disturbances associated with ptsd, the strength of this dissociation provides evidence that trauma-related nightmares are effectively targeted by the nightware device.Nightware on their website reports "efficacy over placebo".Nightware demonstrated efficacy over placebo during clinical trials.It exhibited a 3.2-point improvement on the pittsburgh sleep quality improvement scale in an ongoing randomized controlled trial.This exceeds the minimal clinically important difference.The psqi-a improvement was more than double that of the sham device.Additionally, nightware states the following: "before the fda clears any device or drug for marketing to the public, the manufacturer must demonstrate to the agency's satisfaction that the product is effective and safe." these statements are listed on the webpage https://nightware.Com/patient-faq/ please note the fda https://www.Accessdata.Fda.Gov/cdrh_docs/pdf20/den200033.Pdf does not establish that nightware is effective.

• Brand Name: NIGHTWARE
• Type of Device: DIGITAL THERAPY DEVICE TO REDUCE SLEEP DISTURBANCE FOR PSYCHIATRIC CONDITIONS
• Manufacturer (Section D): NIGHTWARE INC.; 8900 excelsior blvd.; hopkins MN 55434
• MDR Report Key: 16461885
• MDR Text Key: 310618351
• Report Number: MW5115337
• Device Sequence Number: 1
• Product Code: QMZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other