MAUDE Adverse Event Report: NOVASOM, INC. ACCUSOM MODEL NS 2010; VENTILATORY EFFORT RECORDER

Model Number NS 2010

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Sleep Dysfunction (2517)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

Prevents sleeping; i was sent a accusom model ns 2010 for a sleep study ordered by dr (b)(6), my primary care physician.Every time i started to fall asleep and my breathing got shallow, the device said "check breath sensor" and woke me up.Heavy breathing on the device or blowing on it would reset it.After five warnings, i called the product support number.That was 7 am.They had me unplug the sensor and plug it back in, untape it from my face and reposition it, and told me if it kept up to stop testing, and they would send me a new sensor.I don't believe the sensor is malfunctioning.I feel like it wakes me when my blood oxygen drops below 90%.Which it commonly does when i sleep, and is why i wanted the sleep study.The staff didn't think it worked that way; but didn't really seem to know how their device actually works.I kept trying to reposition and go to sleep for an add'l hour, and three more reiterations of "check breath sensor" and quit at 3 am.It's a good thing i didn't have to go to work the next day, or drive on four hours of sleep.A sleep study device that has a defective sensor and won't let you sleep, isn't safe.All their clinical specialists were unavailable when i called the next day.I asked my dr to try and reach the company, but she hasn't gotten back to me either.Fda safety report id# (b)(4).

• Brand Name: ACCUSOM MODEL NS 2010
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): NOVASOM, INC.
• MDR Report Key: 9665130
• MDR Text Key: 177883966
• Report Number: MW5092709
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/30/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: NS 2010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 63