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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE HEMO PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number 9.30
Device Problem Computer Software Problem (1112)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2015
Event Type  malfunction  
Manufacturer Narrative
Upon retrospective review, this issue was determined to be an mdr.
 
Event Description
Merge hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. Customer reported an issue of several tabs on a case where locked even when there are no active workstations with the case checked out. This happened on the end study tab, the patient data study tab, labs tab and the study report tab. The hemo client supports concurrent user access. This requires that user interface (ui) elements be locked when one user is viewing / editing ui elements to prevent other users from making changes. Because data is written to the local database, an additional check is made to ensure that the locking data is the same on the server to ensure that all data has replicated to the server before freeing the lock. When a hemo client loses connection to the hemo server, any locks that this client had at the time will remain until that client is able to replicate its data to the server. This results in the inability for the user to be able to edit data for those tabs and chronological log entries. Due to the way that locking was implemented on 9. X systems, and the fact that hemo clients uses a local database, this can result in phantom locks. (b)(4).
 
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Brand NameMERGE HEMO
Type of DevicePROGRAMMABLE DIAGNOSTIC COMPUTER
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 rd
hartland, WI 53029
2629123570
MDR Report Key5437721
MDR Text Key38227922
Report Number2183926-2015-00362
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 Number9.30
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2183926-02/15/2016-048-C

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