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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASY TOUCH BLOOD PRESSURE MONITOR

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MHC MEDICAL PRODUCTS, LLC EASY TOUCH BLOOD PRESSURE MONITOR Back to Search Results
Model Number N/A
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Failure to Shut Off (2939)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 03/30/2018
Event Type  malfunction  
Event Description
Err displayed on the screen. Thought it may be the batteries so they purchased new ones. When he tried to take his pressure the machine wouldn't shut off after taking his blood pressure.
 
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Brand NameEASY TOUCH
Type of DeviceBLOOD 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 Key7471398
MDR Text Key107355957
Report Number3005798905-2018-00483
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number860213
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/30/2018
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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