MAUDE Adverse Event Report: ITAMAR MEDICAL LTD 12 UPAT PROBES FOR WATCH-PAT; VENTILATORY EFFORT RECORDER

Model Number 12 UPAT PROBES FOR WATCH-PAT

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  malfunction  

Event Description

The patient was given a disposable home sleep test.The patient put the oximeter finger probe on their finger and it "felt hot," the husband used the device too and it felt hot.They swapped it to another finger and the same thing happened.Manufacturer response for sp02 oximeter finger probe, (brand not provided) (per site reporter).Unknown at this time.

• Brand Name: 12 UPAT PROBES FOR WATCH-PAT
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL LTD; 3290 cumberland club drive; suite 100; atlanta GA 30339
• MDR Report Key: 15515007
• MDR Text Key: 300901196
• Report Number: 15515007
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2022

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 Model Number: 12 UPAT PROBES FOR WATCH-PAT
• Device Catalogue Number: AC2101300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2022
• Event Location: Other
• Date Report to Manufacturer: 09/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7300 DA
• Patient Sex: Female
• Patient Weight: 87 KG