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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 Problem Failure to Pump (1502)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2018
Event Type  malfunction  
Event Description
It wouldn't pump up as tight as it used to.It then would only pump up to 200 then count down, but during count down, it would stop and start pumping up again.It then would only pump up to 150 and the machine would do the same thing.He replaced the batteries yesterday to see if that would help.The same problems occurred, and now it displays an error p on the screen.Based on the information provided, a replacement will be sent and a return label requested.
 
Event Description
It wouldn't pump up as tight as it used to.It then would only pump up to 200 then count down, but during count down, it would stop and start pumping up again.It then would only pump up to 150 and the machine would do the same thing.He replaced the batteries yesterday to see if that would help.The same problems occurred, and now it displays an error p on the screen.Based on the information provided, a replacement will be sent and a return label requested.
 
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Brand Name
SURELIFE
Type of Device
BLOOD PRESSURE MONITOR
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
MDR Report Key7728837
MDR Text Key115353422
Report Number3005798905-2018-00738
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
PMA/PMN Number
K091415
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Replace
Type of Report Initial,Followup
Report Date 07/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number860211
Device Lot Number42792
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Date Manufacturer Received06/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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