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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODCUTS, LLC. SURELIFE BLOOD PRESSURE MONITOR

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MHC MEDICAL PRODCUTS, LLC. SURELIFE BLOOD PRESSURE MONITOR Back to Search Results
Catalog Number 860212
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Incorrect Or Inadequate Test Results (2456)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 03/16/2018
Event Type  malfunction  
Event Description
Sporadic inaccurate readings.
 
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Brand NameSURELIFE
Type of DeviceBLOOD PRESSURE MONITOR
Manufacturer (Section D)
MHC MEDICAL PRODCUTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
Manufacturer (Section G)
MHC MEDICAL PRODCUTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnati, OH 45240
MDR Report Key7653187
MDR Text Key112916085
Report Number3005798905-2018-00946
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 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number860212
Device Lot Number43895
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/16/2018
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

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