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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVONGO HEALTH INC LIVONGO BLOOD PRESSURE MONITOR
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LIVONGO HEALTH INC LIVONGO BLOOD PRESSURE MONITOR Back to Search Results
Model Number HT900
Device Problem Inflation Problem (1310)
Patient Problem Ecchymosis (1818)
Event Date 11/17/2022
Event Type  Injury  
Event Description
The member reported that while using their livongo blood pressure monitor the monitor became too tight and left contusions on their arm.
 
Manufacturer Narrative
The device associated with this event was returned to the manufacturer and underwent testing.The testing did not reveal any issues with the device, as the device performed as intended.The reported event of the cuff overinflating was unable to be reproduced.
 
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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 94041
Manufacturer (Section G)
LIVONGO HEALTH INC
150 w evelyn ave
unit 150
mountain view 94041
Manufacturer Contact
jacob gendler
150 w evelyn ave
unit 150
mountain view 94041
MDR Report Key16000554
MDR Text Key305681549
Report Number3011196194-2022-00033
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
PMA/PMN Number
K131395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberHT900
Device Catalogue NumberOFG15760
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2022
Initial Date Manufacturer Received 11/29/2022
Initial Date FDA Received12/16/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
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