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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
Catalog Number 860212
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2018
Event Type  malfunction  
Event Description
Inaccurate readings compared to another device led to a resulting visit to medical care.
 
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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 PRODCUTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnati, OH 45240
MDR Report Key7982706
MDR Text Key124267258
Report Number3005798905-2018-02705
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
Report Date 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number860212
Device Lot Number42795
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2018
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 Reuse

Patient Treatment Data
Date Received: 10/18/2018 Patient Sequence Number: 1
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