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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Transmit Record (1521); Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2017
Event Type  malfunction  
Manufacturer Narrative
The customer reported to merge technical support that prior to calling into merge healthcare, there was a connection issue with the link assembly so the medical staff rebooted the hemo monitor pc only. This interrupted the connection to the client pc and caused the hemo physio controls to be grayed out. Technical support assisted the customer in the proper reboot sequence. An internal investigation conducted by merge healthcare found that if the hemo monitor pc is powered up and there is no active network connection, the hemo monitor pc will report an appropriate error to the event log, but currently will not attempt any retries to establish the connection to the hemo client pc. No active network connection can occur if the cable between the hemo monitor pc and hemo client pc is disconnected, or if the hemo client pc has not been powered up. When communication fails, patient vitals continue to be displayed on the hemo monitor pc except for non-invasive blood pressure (nibp) data. This requires a reboot/restart of the hemo monitor pc which interrupts the ability to capture and document patient vitals. This problem has been addressed ((b)(4)) and will be corrected in a future release, merge hemo v10. 2. (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 connection to the hemo monitor was lost in the middle of a procedure. The user rebooted the hemo monitor only causing the physio controls to be grayed out on the hemo client pc. Subsequently, the hemo monitor and the client pc both had to be rebooted a second time so that the proper connection could be established. This resulted in a loss of patient monitoring. With merge hemo not capturing physiological data, there is a potential for delay of treatment that could result in harm to the patient. However, the procedure was completed successfully once the hemo monitor and client pc were rebooted using the proper sequence. (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 Key6716422
MDR Text Key80142680
Report Number2183926-2017-00148
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 06/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2017
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 Received06/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
Removal/Correction Number2183926-02/15/2016-041-C

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