MAUDE Adverse Event Report: ITAMAR MEDICAL LTD WATCH-PAT 200; VENTILATORY EFFORT RECORDER

Lot Number UNI1017617

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burning Sensation (2146)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

The patient was given a watchpat 200 home sleep test unit.After using the sao2 finger probe, the patient informed us the following morning that the probe was "burning her finger".She tried to adjust it, but ultimately could not relieve that burning sensation.

• Brand Name: WATCH-PAT 200
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL LTD; 3290 cumberland club drive; suite 100; atlanta GA 30339
• MDR Report Key: 16407958
• MDR Text Key: 309895488
• Report Number: 16407958
• 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: 02/13/2023,02/08/2023

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 Lot Number: UNI1017617
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Home
• Date Report to Manufacturer: 02/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Sex: Female
• Patient Weight: 75 KG