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

Model Number P1716

Device Problem Unintended Electrical Shock (4018)

Patient Problems Increased Sensitivity (4538); Skin Inflammation/ Irritation (4545)

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

Medwatch uf/importer report# 2200350000-2023-8010 h3 other text : device ot returned to manufacturer.

Event 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
• Type of Device: 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
• MDR Text Key: 337314348
• Report Number: 2518422-2024-12776
• Device Sequence Number: 1
• Product Code: MNR
• UDI-Device Identifier: 00606959011243
• UDI-Public: 00606959011243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Race: White