MAUDE Adverse Event Report: ITAMAR MEDICAL, LTD (ALCON) WATCHPAT ONE; VENTILATORY EFFORT RECORDER

Patient Problems Pain (1994); Sleep Dysfunction (2517)

Event Date 09/16/2023

Event Type  Injury  

Event Description

Finger oximetry attachment was so tight that it cut off circulation and was painful that i woke up and had to remove it.This renders the sleep study invalid.

• Brand Name: WATCHPAT ONE
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL, LTD (ALCON)
• MDR Report Key: 17788927
• MDR Text Key: 324059729
• Report Number: MW5145997
• 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: Unknown
• Type of Report: Initial
• Report Date: 09/18/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2023
• Patient Sequence Number: 1
• Treatment: METOPROLOL XL.; ROSUVASTATIN.; SEMAGLUTIDE.
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian