MAUDE Adverse Event Report: ITAMAR MEDICAL, INC. WATCHPAT 300; VENTILATORY EFFORT RECORDER

Model Number WATCH-PAT300

Device Problem Lack of Effect (4065)

Patient Problems Discomfort (2330); Superficial (First Degree) Burn (2685); Blister (4537)

Event Date 12/10/2022

Event Type  malfunction  

Event Description

Patient returned a home sleep apnea testing device (watchpat 300 sn).The patient stated the machine didn¿t appear to be working and that when he took the device off, there were 3 small burn marks on his finger.When putting the probe on his index finger it was very tight, then it didn't seem like the machine wanted to turn on the way the directions read the next day.His finger had a sensation all day long and the following morning he woke up with blisters.

• Brand Name: WATCHPAT 300
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL, INC.; 3290 cumberland club dr, ste 100; atlanta GA 30339
• MDR Report Key: 16130382
• MDR Text Key: 307018660
• Report Number: 16130382
• 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: 12/15/2022

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: WATCH-PAT300
• Device Catalogue Number: WATCH-PAT300
• 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: 12/15/2022
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 01/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other