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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 04/02/2024

Event Type  Injury  

Event Description

When doing an at home sleep study with the watch pat one product, i suffered a burn from the oxygen sensor to my finger from the light inside.

• Brand Name: WATCHPAT ONE
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL INC.
• MDR Report Key: 19070509
• MDR Text Key: 339835295
• Report Number: MW5153647
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2024
• Patient Sequence Number: 1
• Treatment: FLONASE.; LEXAPRO.; LISINOPRIL.; MAGNESIUM B-2.; MULTIVITAMIN.; SUMATRIPTAN (AS NEEDED).
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White