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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC SURELIFE ARM BLOOD PRESSURE MONITOR

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MHC MEDICAL PRODUCTS, LLC SURELIFE ARM BLOOD PRESSURE MONITOR Back to Search Results
Catalog Number 860214
Device Problem Incorrect Measurement (1383)
Patient Problem No Code Available (3191)
Event Date 03/26/2018
Event Type  malfunction  
Manufacturer Narrative
No lot number or serial number was provided. Product will be evaluated upon receipt.
 
Event Description
Monitor giving high readings 130-200's. He goes to the dr to get checked out and his bp is actually normal bp is 120/170 or 80 issue has been going on for 2 months and continues to go back to the dr office because he thinks his bp is on high side.
 
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Brand NameSURELIFE
Type of DeviceARM BLOOD PRESSURE MONITOR
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 Key7463462
MDR Text Key106843340
Report Number3005798905-2018-00475
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
Type of Report Initial
Report Date 04/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number860214
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 Received03/26/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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