Snore Sensor SNORE MICROPHONERecalls & reported problems
Respironics, Inc. · SNORE MICROPHONE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00606959011243), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Electrical Shock” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Electrical Shock1
Patient problems
- Hyperresponsive to stimuli1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2024Unintended Electrical Shock; Unintended Electrical Shock
THE MANUFACTURER RECEIVED INFORMATION VIA A VOLUNTARY MEDWATCH REPORT REGARDING A PRO-TECH SNORE SENSOR. A COUPLE OF DAYS FOLLOWING A SLEEP STUDY, A PATIENT ALLEGED TO HAVE RECEIVED A SHOCK FROM AN ELECTRODE ON HIS NECK THAT LEFT A RED MARK AND SCAB. THE PATIENT STATED DURING THE SLEEP STUDY, WHILE JUST FALLING ASLEEP, THE PATIENT WAS AWOKEN BY A SHOCK ON THE NECK THAT LASTED A FEW SECONDS. THE PATIENT DID NOT REPORT THE EVENT AT THE TIME OF OCCURRENCE, AND JUST FELL BACK TO SLEEP. THE FOLLOWING MORNING, WHILE IN THE SHOWER, THE PATIENT REALIZED A SENSITIVE SPOT ON THE NECK WHERE THE "PRO-TECH SNORE MIC" WAS LOCATED. THE PATIENT STATED THERE WAS A RED MARK AND A SMALL SCAB IN THE AREA WHERE THE DEVICE WAS LOCATED. THE PATIENT WAS WEARING A SILVER CHAIN AT THE TIME OF THE INCIDENT.
Patient problems: Hyperresponsive to stimuli; Skin Inflammation/ Irritation
MAUDE report 18865293 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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