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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODCUTS, LLC. SURELIFE BPM

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MHC MEDICAL PRODCUTS, LLC. SURELIFE BPM Back to Search Results
Catalog Number 860213
Device Problems Failure to Pump (1502); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Operational Issue (2914); Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2018
Event Type  malfunction  
Event Description
(b)(6) calling in on behalf of her husband, bpm isn't working. Changed the batteries and did all the troubleshooting, but the arm cuff still isn't functioning as it should. Not pumping displaying error code p.
 
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Brand NameSURELIFE
Type of DeviceBPM
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 Key7632316
MDR Text Key112144663
Report Number3005798905-2018-00625
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 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Catalogue Number860213
Device Lot Number1604
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 Received05/22/2018
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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