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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 Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460); Device Operational Issue (2914); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2018
Event Type  malfunction  
Event Description
Results received from the device are off by 30 points (inaccurate readings).Customer's normal blood pressure is 124/72.Monitor results: 99/57, 98/51, and 97/54.
 
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Brand Name
SURELIFE WRIST BP MONITOR-CLASSIC
Type of Device
SYSTEM, 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 Key7617404
MDR Text Key111644341
Report Number3005798905-2018-02430
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
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number860211
Device Lot Number43893
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/21/2018
Initial Date FDA Received06/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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