• 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. SURE LIFE BLOOD PRESSURE MONITORI

  • 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. SURE LIFE BLOOD PRESSURE MONITORI Back to Search Results
Catalog Number 860213
Device Problems Device Operational Issue (2914); Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2018
Event Type  malfunction  
Event Description
Bpm is no longer pushing out air.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURE LIFE
Type of DeviceBLOOD PRESSURE MONITORI
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC.
11930 kemper springs drive
cincinnnati OH 45240
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC.
11930 kemper springs drive
cincinnnati OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnnati, OH 45240
MDR Report Key7580501
MDR Text Key110452089
Report Number3005798905-2018-00576
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 06/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number860213
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 Received05/07/2018
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

-
-