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

Model Number 139515

Patient Problems Discomfort (2330); Sleep Dysfunction (2517); Superficial (First Degree) Burn (2685)

Event Date 06/28/2023

Event Type  malfunction  

Event Description

(b)(6) 2023 11:29 am by risk, rde--- patient was placed on watchpat sleep testing device (b)(6) 2023.Patient returned the device the next day.The patient came back with a burn on his left index finger from the pulse oximeter.It disturbed his sleep and he had to take it off due to intense discomfort.Manager spoke to patient and offered site to be assessed in auc or with primary care physician.Member declined and said that he was not in pain nor was the site swollen.Device was removed from rotation and will need to be tested and inspected by the vendor for safety.

• Brand Name: WATCHPAT 300
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL
• MDR Report Key: 17407005
• MDR Text Key: 320081206
• Report Number: MW5120179
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/21/2023

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: Health Professional
• Device Model Number: 139515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other