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

Model Number HT900

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

Event Date 03/11/2023

Event Type  Injury  

Manufacturer Narrative

The blood pressure monitor was requested back from the patient but has not yet been returned.If the device is returned an investigation will be conducted and a supplemental report will be filed.

Event Description

Patient reported the livongo blood pressure monitor cuff caused them pain and cut off circulation on their arm.

• Brand Name: LIVONGO 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): TELADOC HEALTH, INC.; 150 w evelyn ave; unit 150; mountain view CA 94041
• Manufacturer Contact: jacob gendler ; 150 w evelyn ave; unit 150; mountain view, CA
• MDR Report Key: 16686696
• MDR Text Key: 312761808
• Report Number: 3011196194-2023-00034
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HT900
• Device Catalogue Number: OFG15760
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female