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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC SURELIFE WRIST BP MONITOR-PREMIUM SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE

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MHC MEDICAL PRODUCTS, LLC SURELIFE WRIST BP MONITOR-PREMIUM SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE Back to Search Results
Catalog Number 860212
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); High Test Results (2457); Device Operational Issue (2914); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2017
Event Type  malfunction  
Event Description
End user's monitor is giving extremely high readings.
 
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Brand NameSURELIFE WRIST BP MONITOR-PREMIUM
Type of DeviceSYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
11930 kemper springs drive
cincinnati OH 45240
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnati, OH 45240
MDR Report Key7632170
MDR Text Key112166519
Report Number3005798905-2018-02152
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091415
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Remedial Action Replace
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number860212
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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