MAUDE Adverse Event Report: LIVONGO HEALTH INC LIVONGO BLOOD PRESSURE MONITOR

Model Number UA-651-BLE

Device Problem Overheating of Device (1437)

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

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The livongo blood pressure monitor have not been returned to the manufacturer.Should the device be returned, a supplemental report will be filed with the results of the testing.

Event Description

The patient reported that the batteries inside of their hypertension monitor leaked.

• Brand Name: LIVONGO BLOOD PRESSURE MONITOR
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): LIVONGO HEALTH INC; 150 w. evelyn ave; suite 150; mountain view CA 94041
• Manufacturer (Section G): LIVONGO HEALTH INC; 150 w. evelyn ave; suite 150; mountain view CA 94041
• Manufacturer Contact: michael chibbaro ; 150 w. evelyn ave; suite 150; mountain view, CA 94041
• MDR Report Key: 10523599
• MDR Text Key: 207379209
• Report Number: 3011196194-2020-00036
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K170196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/11/2020

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: No Information
• Device Model Number: UA-651-BLE
• Device Catalogue Number: OFG01779
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 39 YR