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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

Hello, my complaint is with the watchpat device.I had a recent sleep study on (b)(6) 2022.Unfortunately, i was unable to sleep and was up the whole night, however, the device measured a sleep time of over 5 hours for me.Due to this inaccurate and invalid report, my physician believes i slept and considers my study to be correct.This ultimately affects my treatment and care as a patient.My complaint is that the device is not capable of accurately assessing if a patient is actually asleep or not.Due to this, the diagnostic test which was supposed to help me, failed in the most basic sense and potentially left a patient without the treatment they needed.Thank you.Fda safety report id# (b)(4).

• Brand Name: WATCHPAT 300
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL
• MDR Report Key: 13666854
• MDR Text Key: 286659176
• Report Number: MW5107886
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/02/2022

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 Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2022
• Patient Sequence Number: 1
• Patient Sex: Male