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

Model Number HT900

Device Problems Deflation Problem (1149); Failure to Deflate (4060)

Patient Problems Pain (1994); Numbness (2415)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

The member reported the blood pressure cuff for continuous inflation during a reading which caused feelings of pain and numbness in one of their left fingers for 3 to 4 weeks.

Manufacturer Narrative

The blood pressure monitor was requested for return but has not yet been received.Should the device be received a supplemental report shall be filed.Member reported that the blood pressure monitor cuff was continuously inflating, causing what felt like cut-off of circulation and numbness in left index finger that lasted 3-4 weeks.This report is being filed due to potential injury to member and potential injury if issue were to reoccur.

• 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): LIVONGO HEALTH, INC; 150 w evelyn ave; unit 150; mountain view CA 94041
• Manufacturer Contact: jacob gendler ; 150 w evelyn ave; unit 150; mountaiin view, CA 94041
• MDR Report Key: 15117320
• MDR Text Key: 304594023
• Report Number: 3011196194-2022-00010
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: HT900
• Device Catalogue Number: OFG0159
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR