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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC SURELIFE BLOOD PRESSURE CUFF (ARM)

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MHC MEDICAL PRODUCTS, LLC SURELIFE BLOOD PRESSURE CUFF (ARM) Back to Search Results
Model Number NOT PROVIDED
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Displays Incorrect Message (2591); Output Problem (3005)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2017
Event Type  malfunction  
Event Description
Customer receives "err p", "err 1", and "err 3" on display.
 
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Brand NameSURELIFE
Type of DeviceBLOOD PRESSURE CUFF (ARM)
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
11930 kemper springs drive
cincinnati, oh OH 45240
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC
11930 kemper springs drive
cincinnati, oh OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnati, oh, OH 45240
5136745932
MDR Report Key7366552
MDR Text Key103566123
Report Number3005798905-2018-00001
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,Followup
Report Date 02/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNOT PROVIDED
Device Catalogue Number860214
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/05/2017
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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