MAUDE Adverse Event Report: ECTOSENSE NV NIGHTOWL HOME SLEEP TEST; VENTILATORY EFFORT RECORDER

Model Number 7079589

Patient Problems Apnea (1720); Tachycardia (2095); Malaise (2359)

Event Date 06/26/2023

Event Type  Injury  

Event Description

I began using the cpap on (b)(6), 2023.After about three days of usage, i noticed my heart rate was over 100 beats per minute and my heart began to flitter and jump and shake.I felt awful throughout the day and thought it was my heart and not the cpap.I brought this to the attention of my pcp, and they really thought i was kidding, i think, as they offered me no solutions.I paused the use of the cpap on (b)(6), 2023, to determine if the cpap was the issue and after three days, my symptoms disappeared.I then restarted the usage of the cpap on (b)(6) and used it until (b)(6), 2023, and finally decided it was the cpap and ceased usage altogether on (b)(6), 2023.I scheduled an appointment with a cardiologist, and he referred me to a pulmonologist who informed me that there were no other solutions except a mandibular device to prevent sleep apnea.None of the specialists of my pcp had never had this complaint from a patient before and really did not know what to do with me.I will say this.Adapt health is the company my pcp referred me to for a sleep study.The company mailed a nightowl home sleep test to me.The numbers on the back of this package is code (b)(4), the gtin is (b)(4), the device expires on 12/31/2024 and the barcode number is (b)(4).This device is assembled to tape to your finger and you sleep with it on.The data is sent to an app on my cellphone and then uploaded to supposedly a physician who reads the data and produces a report.I was surprised the pulmonologist failed to repeat the sleep study with the traditional method of wires attached to my body and connected to a device i bring home.I have zero faith in this nighowl method.I do know this warrants an investigation because this device should not cause cardiac issues.If nothing else, it would decrease the risk of cardiac conditions or disease by pushing oxygen to my organs.Reference report: mw5145705.

• Brand Name: NIGHTOWL HOME SLEEP TEST
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ECTOSENSE NV
• MDR Report Key: 17764034
• MDR Text Key: 323752054
• Report Number: MW5145706
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/13/2023

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: Lay User/Patient
• Device Model Number: 7079589
• Device Catalogue Number: 20NEV4CB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2023
• Patient Sequence Number: 1
• Treatment: LACTULOSE.; EPCLUSA.; PEPCID AC. ; PRILOSEC.; TYLENOL.
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White