MAUDE Adverse Event Report: ITAMAR MEDICAL LTD WATCHPATONE; VENTILATORY EFFORT RECORDER

Model Number WATCHPATONE

Device Problem Overheating of Device (1437)

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

Patient used the watchpat sleep study device at home overnight but unfortunately the watch portion of the device became very hot after time to the point where caused a second-degree burn on the dorsum of the wrist.Patient states there several blisters surrounded by erythematous rings.

• Brand Name: WATCHPATONE
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL LTD; 3290 cumberland club drive; suite 100; atlanta GA 30339
• MDR Report Key: 12950913
• MDR Text Key: 281849443
• Report Number: 12950913
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2021

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: Lay User/Patient
• Device Model Number: WATCHPATONE
• Device Catalogue Number: AC2110800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2021
• Event Location: Home
• Date Report to Manufacturer: 12/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other