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U.S. Department of Health and Human Services

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

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MHC MEDICAL PRODUCTS, LLC SURELIFE BLOOD PRESSURE MONITOR Back to Search Results
Model Number NOT PROVIDED
Device Problem Overheating of Device (1437)
Patient Problem No Information (3190)
Event Date 07/11/2016
Event Type  malfunction  
Event Description
Device overheated upon changing battery.
 
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Brand NameSURELIFE
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
8773584342
MDR Report Key7365659
MDR Text Key103528806
Report Number3005798905-2018-00005
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K0941415
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 02/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Model NumberNOT PROVIDED
Device Catalogue Number860211
Device Lot NumberNOT PROVIDED
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 Received07/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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