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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. EASY TOUCH BPM

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MHC MEDICAL PRODUCTS, LLC. EASY TOUCH BPM Back to Search Results
Catalog Number 860213
Device Problems Infusion or Flow Problem (2964); Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/02/2018
Event Type  malfunction  
Event Description
Machine comes on, button lights up, it's just the cuff won't pump up.
 
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Brand NameEASY TOUCH
Type of DeviceBPM
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC.
11930 kemper springs drive
cincinnnati OH 45240
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC.
11930 kemper springs drive
cincinnnati OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnnati, OH 45240
MDR Report Key7576488
MDR Text Key110328459
Report Number3005798905-2018-00568
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 06/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number860213
Device Lot Number1604
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/02/2018
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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