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

Model Number ITAMAR WATCHPAT 200 - UNIFIED

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

Patient Problem Blister (4537)

Event Date 02/24/2021

Event Type  malfunction  

Event Description

Patient was using the itamar watchpat home sleep apnea test and when she removed the device in the morning, she had a sore on her finger, near her fingernail, cuticle region.It resembled a blister and was red with a white center and painful.In speaking with her later on, she notes that the sore has nearly fully resolved.

• 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: 11403868
• MDR Text Key: 234433374
• Report Number: 11403868
• 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: 03/02/2021

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: ITAMAR WATCHPAT 200 - UNIFIED
• Device Catalogue Number: AC2101300
• 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: 03/02/2021
• Event Location: Home
• Date Report to Manufacturer: 03/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2021
• 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: 9125 DA
• Patient Weight: 59