• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIVONGO HEALTH INC LIVONGO BLOOD PRESSUE MONITOR BLOOD PRESSURE MONITOR Back to Search Results
Model Number HT900
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  malfunction  
Manufacturer Narrative
The livongo blood presure monitor has 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 customer reported that their hypertension monitor started to smell like it was smoking when they were using it. The customer stated that the back of the hypertension monitor had melted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIVONGO BLOOD PRESSUE MONITOR
Type of DeviceBLOOD PRESSURE MONITOR
Manufacturer (Section D)
LIVONGO HEALTH INC
150 w. evelyn ave
suite 150
mountain view CA 94041
Manufacturer (Section G)
LIVONO HEALTH INC
150 w. evelyn ave
suite 150 CA 94041
Manufacturer Contact
michael chibbaro
150 w. evelyn ave
suite 150
mountain view, CA 94041
MDR Report Key11649062
MDR Text Key245112615
Report Number3011196194-2021-00007
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
PMA/PMN Number
K170196
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Replace
Type of Report Initial
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHT900
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 04/12/2021 Patient Sequence Number: 1
-
-