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U.S. Department of Health and Human Services

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

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MHC MEDICAL PRODCUTS, LLC. SURE LIFE BLOOD PRESSURE MONITOR Back to Search Results
Catalog Number 860224
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2018
Event Type  malfunction  
Event Description
The cuff broke off from the bpm where the tube meets the part that feeds into the monitor.
 
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Brand NameSURE LIFE
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 Key7754881
MDR Text Key116219102
Report Number3005798905-2018-00764
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
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 07/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number860224
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2018
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

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