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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC SURELIFE ARM BP MONITOR-CLASSIC; SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE
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MHC MEDICAL PRODUCTS, LLC SURELIFE ARM BP MONITOR-CLASSIC; SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE Back to Search Results
Catalog Number 860213
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2017
Event Type  malfunction  
Event Description
Monitors were returned by customer's of (b)(6) drugstore because they were receiving error 1 messages.Drugstore owner would like replacements for his store.
 
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Brand Name
SURELIFE ARM BP MONITOR-CLASSIC
Type of Device
SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE
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 Key7632105
MDR Text Key112171948
Report Number3005798905-2018-02216
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,health professional
Reporter Occupation Pharmacist
Remedial Action Replace
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number860213
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly;
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