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

Model Number SNORE MICROPHONE

Device Problem Use of Device Problem (1670)

Patient Problems Erythema (1840); Shock from Patient Lead(s) (3162)

Event Date 06/20/2023

Event Type  malfunction  

Event Description

Patient was in for a sleep study.A couple days later, he reached out to his pcp about follow up and mentioned that he received a "shock" from an electrode on his neck that left a red mark and scab.Pcp informed sleep clinic manager of the complaint.The sleep clinic manager spoke with the patient about his experience.He stated he was just falling asleep, and he was awoken by a shock on his neck that lasted a few seconds.He didn't report it at the time and he fell back to sleep.In the morning when he went home he was in the shower and realized he had a sensitive spot on his neck where the "pro-tech snore mic" was.It had left a red mark which has now left a small scab.He stated that he was wearing a silver chain at the time of the incident.Sleep study tech was questioned about the incident as well.The sleep clinic manger has looked at the recording of the sleep study and didn't come across any noticeable malfunction of the equipment within the recording, but she has taken the equipment out of circulation and will have electrical engineering inspect the equipment.The manufacturers guidelines have been reviewed and nothing instructs differently or warn against possible shock from the way it was used.

• Brand Name: SNORE SENSOR
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15206
• MDR Report Key: 17332289
• MDR Text Key: 319113492
• Report Number: 17332289
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/28/2023

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 Model Number: SNORE MICROPHONE
• Device Catalogue Number: P1716
• Device Lot Number: 85636327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2023
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18980 DA
• Patient Sex: Male
• Patient Race: White