MAUDE Adverse Event Report: LIVONGO HEALTH INC LIVONGO A/C ADAPTOR

Device Problems Fire (1245); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

The a/c adaptor has not been returned to the manufacturer.The patient was sent a replacement adaptor.An investigation will be performed but has not yet begun.

Event Description

The member alleged the charger melted and started a small fire in his bathroom.

• Brand Name: LIVONGO A/C ADAPTOR
• Type of Device: A/C ADAPTOR
• 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: 12797625
• MDR Text Key: 281659949
• Report Number: 3011196194-2021-00020
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K133584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female