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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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MERGE HEALTHCARE MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number HEMO V. 9.20
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2014
Event Type  malfunction  
Manufacturer Narrative
Upon retrospective review, this issue was determined to be reportable as an mdr.
 
Event Description
Merge hemo monitors, measures, and records physiologic data from human patients undergoing a cardiac catheterization procedure. Customer reported hemo monitor crashed with an error hemomonitor. Exe error. The site lost vitals monitoring and logs attached. (b)(4).
 
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Brand NameMERGE HEMO
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
michael diedrick
900 walnut ridge dr.
hartland, WI 53029
2629123570
MDR Report Key5437924
MDR Text Key38226571
Report Number2183926-2015-00388
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 02/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHEMO V. 9.20
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number2183926-02/15/2016-031-C

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