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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 860211
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2018
Event Type  malfunction  
Event Description
Initial inquiry: error p is showing on the screen during initial turn on but will inflate and show a bpm reading and inflate. She wants to be sure her readings are accurate. I called to speak with (b)(6) and she stated a p just shows up on the screen, not an err p. The p will just flash and then the machine will provide her with a reading that she's not comfortable with. She would like a replacement due to her having heart problems.
 
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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
MDR Report Key7844422
MDR Text Key119152752
Report Number3005798905-2018-00864
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 08/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number860211
Device Lot Number42793
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2018
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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