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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 9.40
Device Problem Failure to Transmit Record (1521)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2016
Event Type  malfunction  
Manufacturer Narrative
Merge healthcare conducted an internal quality investigation to address the issue reported in recall (b)(4), fda recall number (b)(4). Merge healthcare received reports of the hemo monitor application unexpectedly stopping to display and update patient data. When this issue occurs, the hemodynamics system is no longer capturing patient data. For customers who experience this issue, it is recommended that the hemo monitor pc is power cycled. Once the system is powered up, the hemo application should restart with normal functionality and will once again display, update and record patient data. The restarting of the hemo monitor pc may result 0630in a delay of up to two minutes while the system reboots. The investigation and troubleshooting activities conducted by merge healthcare found that the issue occurred due to an error when interfacing with a specific location within a schiller pdm (patient data module) file. Merge has validated and released a firmware fix for this issue. This fix is incorporated into the software upgrade of merge hemo 9. 40. 3 patch 1 (or later), or merge hemo 10. 0. 3 patch 1 (or later). The correction has been verified to be effective as is evidenced through the large reduction of customer complaints concerning this issue.
 
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) 2016, a customer reported to merge healthcare that the hemo monitor stopped working after a patient was sedated and connected to active monitoring. The customer stated there was "a slight delay" while the hemo monitor was rebooted and then no further issues were encountered. With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient. However, the customer stated that the procedure was completed successfully once the hemo monitor was manually rebooted. Reference complaint (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 Key8353535
MDR Text Key136854801
Report Number2183926-2016-00644
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 06/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE HEMODYNAMICS 9.40
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0665-2017

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