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

Model Number UA-651BLE-LIV

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

This device is not intended to undergo charging.Device is intended to either be used with battery power or with electrical power.User also did not use the appropriate charger while plugging in their device, which manufacturer feels led to batteries leaking/melting.The htn 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 after charging their htn monitor, the device was extremely warm.Upon opening the battery compartment, the patient found that the batteries had melted.

• 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
• Manufacturer (Section G): LIVONGO HEALTH INC; 150 w. evelyn ave; suite 150; mountain view, ca
• Manufacturer Contact: michael chibbaro ; 150 w. evelyn ave; suite 150; mountain view, ca
• MDR Report Key: 10468892
• MDR Text Key: 204903464
• Report Number: 3011196194-2020-00032
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UA-651BLE-LIV
• Device Catalogue Number: OFG01779
• Was Device Available for Evaluation?: No
• 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: 43 YR