MAUDE Adverse Event Report: LIVONGO HEALTH, INC. LIVONO BLOOD PRESSURE MONITOR

Model Number HT900

Device Problem Failure to Deflate (4060)

Patient Problem Pain (1994)

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

The patient stated that their livongo blood pressure cuff would not deflate and was causing them pain.The patient was sent a replacement device to resolve the issue, and the device was not returned for evaluation.

Event Description

The patient stated that the cuff on the livongo blood pressure monitor would continuously infllate, and would not stop until she removed the batteries.The start/stop button would not turn the device off.The patient stated that this caused alot of pain, but no bruising.

• Brand Name: LIVONO BLOOD PRESSURE MONITOR
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): LIVONGO HEALTH, INC.; 150 w evelyn ave; unit 150; mountain view CA 94041
• Manufacturer (Section G): LIVONGO HEALTH; 150 w evelyn ave; unit 150; mountain view CA 94041
• Manufacturer Contact: jacob gendler ; 150 w evelyn ave; unit 150; mountain view, CA 94041
• MDR Report Key: 16433226
• MDR Text Key: 310155107
• Report Number: 3011196194-2023-00011
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K131395
• 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: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HT900
• Device Catalogue Number: OFG15760
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female