• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MHC MEDICAL PRODUCTS, LLC EASY TOUCH BLOOD PRESSURE MONITOR Back to Search Results
Model Number N/A
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Low Readings (2460)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 03/30/2018
Event Type  malfunction  
Event Description
Bpm is giving inaccurate readings. Normal bp is 128-130 and the monitor is 98/56. This has been going on for about a month or so he thought it was accurate until he went to the doctor office and they told him the monitor readings weren't right.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7471397
MDR Text Key106866708
Report Number3005798905-2018-00484
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
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 Number860211
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/30/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-