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U.S. Department of Health and Human Services

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

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MHC MEDICAL PRODUCTS, LLC SURELIFE WRIST BP MONITOR-CLASSIC SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE Back to Search Results
Catalog Number 860211
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/02/2018
Event Type  malfunction  
Event Description
Customer receives er1 message. Device deflates too rapidly.
 
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Brand NameSURELIFE WRIST BP MONITOR-CLASSIC
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 Key7617369
MDR Text Key111644797
Report Number3005798905-2018-02392
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 06/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number860211
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? No
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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