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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1
Device Problems Failure to Transmit Record (1521); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2017
Event Type  malfunction  
Manufacturer Narrative
The customer's reported problem is currently under investigation by merge healthcare. For this reason, (b)(4) was used. A supplemental report will be submitted once more information becomes available. (b)(4).
 
Event Description
Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure. The system comprises the patient data module and the merge hemodynamics hemo monitor pc. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the patient data module. This data is then transmitted to the merge hemodynamics hemo monitor pc via the serial interface. All data can be shown and monitored on the merge hemodynamics hemo monitor pc. On (b)(6) 2017, a customer reported to merge healthcare that the ups (uninterrupted power supply) device failed and caused the hemo application to go down during a procedure that affected both the hemo monitor and client pc. Information obtained from the customer found that the issue occurred twice on different days resulting in the keyboard and mouse to lock up. During the first occurrence (date of issue unknown by the customer), the medical staff power cycled the hemo system. During the second occurrence (date reflected in date of event in this report), the keyboard and mouse also locked up but this time the hemo system automatically rebooted itself. It was further reported that the medical staff used a third party portable ekg monitoring system to successfully complete the procedures. After the second occurrence, the hemo system was plugged into a medical grade power strip and no further issues have been reported. With merge hemodynamics not capturing physiological data, there is a potential for delay in treatment that could cause harm to a patient. However, the user confirmed that both procedures were completed successfully using a third party ekg monitoring system. (b)(4).
 
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Brand NameMERGE HEMODYNAMICS
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
meg mucha
900 walnut ridge drive
hartland, WI 53029
2623670700
MDR Report Key6860851
MDR Text Key86009719
Report Number2183926-2017-00178
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 Repair
Type of Report Initial,Followup
Report Date 08/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 10.0.3 PATCH 1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2016
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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