Model 8 8-10000Recalls & reported problems
Snap Diagnostics LLC · The SNAP Model 8 is an at home sleep recorder with five data channels that records respiratory and oximetry data. A nasal/oral cannula houses a pressure sensor that records the respiratory air flow and respiratory sounds. An oximeter is integrated into the device and records oxygen saturation and pulse rate. A respiratory effort belt records respiratory effort and optionally can record body position. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B577810000), received between Mar 21, 2020 and Mar 21, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Electrical Shorting” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Electrical Shorting1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2020Electrical Shorting; Electrical Shorting
THE PATIENT TESTED FOR 3 NIGHTS, DEVICE WAS ON HER DRESSER THAT HAD A THINK CLOTH. THE FIRST TWO NIGHT WERE WITHOUT INCIDENT, "EVERYTHING WAS FINE". THE PATIENT REPORTED THE THIRD NIGHT SHE PLUGGED IN THE MACHINE AND WHEN SHE GOT IN BED SHE NOTICED THERE WAS "SMOKE COMING OUT OF IT". SHE STATES SHE GOT UP AND UNPLUGGED THE DEVICE. THE PATIENT STATES SHE WAS NOT BURNED OR HURT IN ANYWAY. THERE WAS HOWEVER A BURN MARK LEFT ON THE CLOTH COVERING THE TOP OF HER DRESSER AND THE DRESSER ITSELF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9863377 ↗
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- Xltek 2003011Embla Systems Ltd · Ventilatory Effort Recorder3 reports
- Alice NightOne Alice NightOne System, NARespironics, Inc. · VENTILATORY EFFORT RECORDER2 reports
- Alice PDx Alice PDx Sleep Diagnostic System, BRRespironics, Inc. · VENTILATORY EFFORT RECORDER1 report
- Xltek 2013032Embla Systems Ltd · Ventilatory Effort Recorder1 report
- Nox RIP Belts Disposable Large NOX-RIPDL20Nox Medical ehf. · Ventilatory Effort Recorder1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.