MAUDE Adverse Event Report: RESPIRONICS, INC. SNORE MICROPHONE; VENTILATORY EFFORT RECORDER

Model Number	P1716
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Hyperresponsive to stimuli (4538); Skin Inflammation/ Irritation (4545)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medwatch uf/importer report# 2200350000-2023-8010 h3 other text : device ot returned to manufacturer.
Event or Problem Description
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.

• Brand Name: SNORE MICROPHONE
• Common Device Name: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18865293
• Report Number: 2518422-2024-12776
• Device Sequence Number: 19659683
• Product Code: MNR
• UDI-Device Identifier: 00606959011243
• UDI-Public: 00606959011243
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K940015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Operator of Device: Other
• Device Model Number: P1716
• Device Catalogue Number: P1716
• Device Lot Number: 85636327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Race: White