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

Model Number WATCHPAT 200 UNIFIED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Superficial (First Degree) Burn (2685); Blister (4537)

Event Date 07/13/2021

Event Type  malfunction  

Event Description

Patient was using the home sleep testing device at home.Woke up in the middle of the night with pain on her finger that the peripheral arterial tone probe was on.Found a burn blister on her finger just below the nail bed when she removed the device.

• Brand Name: WATCHPAT
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL LTD; 3290 cumberland club drive; suite 100; atlanta GA 30339
• MDR Report Key: 12202011
• MDR Text Key: 262661017
• Report Number: 12202011
• 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: 07/20/2021

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: WATCHPAT 200 UNIFIED
• Device Lot Number: UNI1013714
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2021
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 07/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2021
• 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: 13505 DA