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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC SURELIFE ARM BP MONITOR-CLASSIC; SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE
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MHC MEDICAL PRODUCTS, LLC SURELIFE ARM BP MONITOR-CLASSIC; SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE Back to Search Results
Catalog Number 860213
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 01/06/2017
Event Type  malfunction  
Event Description
Monitor is giving very high readings compared to doctor's office.This is the third time this has been an issue.
 
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Brand Name
SURELIFE ARM 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 Key7632146
MDR Text Key112171414
Report Number3005798905-2018-02174
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091434
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
1 Patient was 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 Lay User/Patient
Device Catalogue Number860213
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/06/2017
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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