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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 06/22/2020

Event Type  Injury  

Event Description

Device causes severe pain to finger when used properly, not sized properly for at home use.At home sleep study test result compromised due to inability to continue test.Their suggestion is to try the pinky, the pinky was not suitable and the pain continued.The expensive at home test device is not suitable for one size fits all prescription and should be sized for the user.The device caused severe pain and the inability to continue the test.Fda safety report id# (b)(4).

• Brand Name: ITAMAR WATCHPAT
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL
• MDR Report Key: 10194817
• MDR Text Key: 196609430
• Report Number: MW5095210
• 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: 06/23/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 82