MAUDE Adverse Event Report: ITAMAR MEDICAL INC SPO2 OXIMETER FINGER PROBE; VENTILATORY EFFORT RECORDER

Lot Number UNI1500677

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Date 12/09/2022

Event Type  malfunction  

Event Description

The patient completed a home sleep apnea test and informed our desk staff about the pressure and burning feeling with the oximeter finger probe.The patient woke up multiple times and felt like she was being shocked or something.It was not all night, but it was like pulsing.

• Brand Name: SPO2 OXIMETER FINGER PROBE
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): ITAMAR MEDICAL INC; 3290 cumberland club dr , ste 100; atlanta GA 30339
• MDR Report Key: 16033289
• MDR Text Key: 305990704
• Report Number: 16033289
• 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: 12/14/2022

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 Lot Number: UNI1500677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2022
• Event Location: Home
• Date Report to Manufacturer: 12/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Sex: Female
• Patient Weight: 56 KG