ACCUSOM MODEL NS 2010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for ACCUSOM MODEL NS 2010 manufactured by Novasom, Inc..

Event Text Entries

[177883966] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092709
• MDR Report Key: 9665130
• Date Received: 2020-02-03
• Date of Report: 2020-01-30
• Date of Event: 2020-01-30
• Date Added to Maude: 2020-02-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ACCUSOM MODEL NS 2010
• Generic Name: VENTILATORY EFFORT RECORDER
• Product Code: MNR
• Date Received: 2020-02-03
• Model Number: NS 2010
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NOVASOM, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-03